Method and apparatus for body fluid sampling and analyte sensing

ABSTRACT

A body fluid sampling system is provided for use on a tissue site. In one embodiment, the system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. Ser. No.10/613,517, filed Jul. 3, 2003, which is a also a continuation-in-partof U.S. patent application Ser. No. 10/425,815 filed May 30, 2003. Said10/613,517 is also a continuation-in-part of U.S. patent applicationSer. No. 10/323,622 filed on Dec. 18, 2002, which is acontinuation-in-part of U.S. patent application Ser. No. 10/127,395filed Apr. 19, 2002. Said 10/613,517 is also a continuation-in-part ofU.S. patent application Ser. No. 10/237,261 filed Sep. 5, 2002. Allapplications listed above are incorporated herein by reference for allpurposes.

BACKGROUND OF THE INVENTION

Lancing devices are known in the medical health-care products industryfor piercing the skin to produce blood for analysis. Typically, a dropof blood for this type of analysis is obtained by making a smallincision in the fingertip, creating a small wound, which generates asmall blood droplet on the surface of the skin.

Early methods of lancing included piercing or slicing the skin with aneedle or razor. Current methods utilize lancing devices that contain amultitude of spring, cam and mass actuators to drive the lancet. Theseinclude cantilever springs, diaphragms, coil springs, as well as gravityplumbs used to drive the lancet. The device may be held against the skinand mechanically triggered to ballistically launch the lancet.Unfortunately, the pain associated with each lancing event using knowntechnology discourages patients from testing. In addition to vibratorystimulation of the skin as the driver impacts the end of a launcherstop, known spring based devices have the possibility of firing lancetsthat harmonically oscillate against the patient tissue, causing multiplestrikes due to recoil. This recoil and multiple strikes of the lancet isone major impediment to patient compliance with a structured glucosemonitoring regime.

Another impediment to patient compliance is the lack of spontaneousblood flow generated by known lancing technology. In addition to thepain as discussed above, a patient may need more than one lancing eventto obtain a blood sample since spontaneous blood generation isunreliable using known lancing technology. Thus the pain is multipliedby the number of attempts required by a patient to successfully generatespontaneous blood flow. Different skin thickness may yield differentresults in terms of pain perception, blood yield and success rate ofobtaining blood between different users of the lancing device. Knowndevices poorly account for these skin thickness variations.

A still further impediment to improved compliance with glucosemonitoring are the many steps and inconvenience associated with eachlancing event. Many diabetic patients that are insulin dependent mayneed to self-test for blood glucose levels five to six times daily. Thelarge number of steps required in traditional methods of glucosetesting, ranging from lancing, to milking of blood, applying blood to atest strip, and getting the measurements from the test strip,discourages many diabetic patients from testing their blood glucoselevels as often as recommended. Older patients and those withdeteriorating motor skills encounter difficulty loading lancets intolauncher devices, transferring blood onto a test strip, or insertingthin test strips into slots on glucose measurement meters. Additionally,the wound channel left on the patient by known systems may also be of asize that discourages those who are active with their hands or who areworried about healing of those wound channels from testing their glucoselevels.

SUMMARY OF THE INVENTION

The present invention provides solutions for at least some of thedrawbacks discussed above. Specifically, some embodiments of the presentinvention provide a multiple lancet solution to measuring analyte levelsin the body. The invention may use a high density design. The inventionmay provide a plurality of analyte detecting members used to samplefluid from tissue. At least some of these and other objectives describedherein will be met by embodiments of the present invention.

In one aspect of the present invention, a body fluid sampling system isprovided for use on a tissue site. In one embodiment, the systemcomprises a cartridge; a penetrating member driver; a plurality ofpenetrating members arranged in a radial configuration on the cartridgewherein sharpened distal tips of the penetrating members point radiallyoutward; wherein an active one of the penetrating members may beoperatively coupled to the penetrating member driver, the penetratingmember driver moving the active one along a path out of a housing havinga penetrating member exit, into the tissue site, stopping in the tissuesite, and withdrawing out of the tissue site; and a plurality of analytedetecting members, wherein at least one of the analyte detecting membersis positioned to receive fluid from a wound created by the active one ofthe penetrating members, wherein the detecting members are not piercedby the active one of the penetrating members.

In one embodiment of the present invention, a body fluid sampling systemfor use on a tissue site is provided. The system comprises a cartridge;a penetrating member driver; a plurality of penetrating members, eachhaving a proximal end, an elongate portion, and a sharpened distal end,the members arranged in a radial configuration on the cartridge whereinsharpened distal tips of the penetrating members point radially outward;wherein an active one of the penetrating members may be operativelycoupled to the penetrating member driver, the penetrating member drivermoving the active one along a path out of a housing having a penetratingmember exit, into the tissue site, stopping in the tissue site, andwithdrawing out of the tissue site; and a plurality of analyte detectingmembers, wherein at least one of the analyte detecting members ispositioned to receive fluid from a wound created by the active one ofthe penetrating members; wherein the unused analyte detecting membersare arranged in a stack, the penetrating member driver configured to becontrolled to follow a velocity trajectory into the tissue and out ofthe tissue, wherein the velocity into the tissue is at an average speedgreater than an average speed of the penetrating member on thewithdrawal.

In another embodiment of the present invention, a body fluid samplingsystem for use on a tissue site is provided. The system comprises acartridge; a penetrating member driver; a plurality of penetratingmembers arranged in a radial configuration on the cartridge whereinsharpened distal tips of the penetrating members point radially outward;wherein an active one of the penetrating members may be operativelycoupled to the penetrating member driver, the penetrating member drivermoving the active one along a path out of a housing having a penetratingmember exit, into the tissue site, stopping in the tissue site, andwithdrawing out of the tissue site; and a plurality of analyte detectingmembers, wherein at least one of the analyte detecting members ispositioned to receive fluid from a wound created by the active one ofthe penetrating members, wherein the detecting members are not piercedby the active one of the penetrating members; a position sensorpositioned to provide an indication of a position of the penetratingmember during actuation.

In yet another embodiment of the present invention, a body fluidsampling system for use on a tissue site is provided. The systemcomprises a cartridge; a penetrating member driver; a plurality ofpenetrating members arranged in a radial configuration on the cartridgewherein sharpened distal tips of the penetrating members point radiallyoutward; wherein an active one of the penetrating members may beoperatively coupled to the penetrating member driver, the penetratingmember driver moving the active one along a path out of a housing havinga penetrating member exit, into the tissue site, stopping in the tissuesite, and withdrawing out of the tissue site; and a plurality of analytedetecting members, wherein at least one of the analyte detecting membersis positioned to receive fluid from a wound created by the active one ofthe penetrating members, wherein the detecting members are not piercedby the active one of the penetrating members; a coupler on thepenetrating member driver configured to engage at least a portion of theelongate portion of the penetrating member and drive the member along apath into a tissue site and withdrawn from a tissue site.

In a still further another embodiment of the present invention, a bodyfluid sampling system for use on a tissue site is provided. The systemcomprises a cartridge; a penetrating member driver; a plurality ofpenetrating members arranged in a radial configuration on the cartridgewherein sharpened distal tips of the penetrating members point radiallyoutward; wherein an active one of the penetrating members may beoperatively coupled to the penetrating member driver, the penetratingmember driver moving the active one along a path out of a housing havinga penetrating member exit, into the tissue site, stopping in the tissuesite, and withdrawing out of the tissue site; and a plurality of analytedetecting members, wherein at least one of the analyte detecting membersis positioned to receive fluid from a wound created by the active one ofthe penetrating members, wherein the detecting members are not piercedby the active one of the penetrating members; a sterility enclosurecovering at least a tip of the penetrating member, the sterilityenclosure removed from the penetrating member prior to actuation of themember and positioned so that the penetrating member will not contactthe enclosure during actuation.

In another embodiment of the present invention, a body fluid samplingsystem for use on a tissue site is provided. The system comprises acartridge; a penetrating member driver; a plurality of penetratingmembers arranged in a radial configuration on the cartridge whereinsharpened distal tips of the penetrating members point radially outward;wherein an active one of the penetrating members may be operativelycoupled to the penetrating member driver, the penetrating member drivermoving the active one along a path out of a housing having a penetratingmember exit, into the tissue site, stopping in the tissue site, andwithdrawing out of the tissue site; and a plurality of analyte detectingmembers, wherein at least one of the analyte detecting members ispositioned to receive fluid from a wound created by the active one ofthe penetrating members, wherein the detecting members are not piercedby the active one of the penetrating members; a user interface fortransmitting at least one input between a user.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating a system, according to anembodiment for use in piercing skin to obtain a blood sample;

FIG. 2 is a plan view of a portion of a replaceable penetrating membercartridge forming part of the system;

FIG. 3 is a cross-sectional end view on 3-3 in FIG. 2;

FIG. 4 is a cross-sectional end view on 4-4 in FIG. 2;

FIG. 5 is a perspective view of an apparatus forming part of the systemand used for manipulating components of the cartridge, illustratingpivoting of a penetrating member accelerator in a downward direction;

FIG. 6A is a view similar to FIG. 5, illustrating how the cartridge isrotated or advanced;

FIG. 6B is a cross-sectional side view illustrating how the penetratingmember accelerator allows for the cartridge to be advanced;

FIGS. 7A and 7B are views similar to FIGS. 6A and 6B, respectively,illustrating pivoting of the penetrating member accelerator in anopposite direction to engage with a select one of the penetratingmembers in the cartridge;

FIGS. 8A and 8B are views similar to FIGS. 7A and 7B, respectively,illustrating how the penetrating member accelerator moves the selectedpenetrating member to pierce skin;

FIGS. 9A and 9B are views similar to FIGS. 8A and 8B, respectively,illustrating how the penetrating member accelerator returns thepenetrating member to its original position;

FIG. 10 is a block diagram illustrating functional components of theapparatus; and

FIG. 11 is an end view illustrating a cartridge according to an optionalembodiment that allows for better adhesion of sterilization barriers.

FIG. 12 is a cross-sectional view of an embodiment having features ofthe invention.

FIG. 13 is a cross-sectional view of an embodiment having features ofthe invention in operation.

FIG. 14 is a cross-sectional view illustrating a low-friction coatingapplied to one penetrating member contact surface.

FIG. 15 is a cross-sectional view illustrating a coating applied to onepenetrating member contact surface which increases friction and improvesthe microscopic contact area between the penetrating member and thepenetrating member contact surface.

FIG. 16 illustrates a portion of a penetrating member cartridge havingan annular configuration with a plurality of radially orientedpenetrating member slots and a distal edge of a drive member disposed inone of the penetrating member slots.

FIG. 17 is an elevational view in partial longitudinal section of acoated penetrating member in contact with a coated penetrating membercontact surface.

FIG. 18 illustrates an embodiment of a lancing device having features ofthe invention.

FIG. 19 is a perspective view of a portion of a penetrating membercartridge base plate having a plurality of penetrating member slots anddrive member guide slots disposed radially inward of and aligned withthe penetrating member slots.

FIGS. 20-22 illustrate a penetrating member cartridge in section, adrive member, a penetrating member and the tip of a patient's fingerduring three sequential phases of a lancing cycle.

FIG. 23 illustrates an embodiment of a penetrating member cartridgehaving features of the invention.

FIG. 24 is an exploded view of a portion of the penetrating membercartridge of FIG. 12.

FIGS. 25 and 26 illustrate a multiple layer sterility barrier disposedover a penetrating member slot being penetrated by the distal end of apenetrating member during a lancing cycle.

FIGS. 27 and 28 illustrate an embodiment of a drive member coupled to adriver wherein the drive member includes a cutting member having asharpened edge which is configured to cut through a sterility barrier ofa penetrating member slot during a lancing cycle in order for the drivemember to make contact with the penetrating member.

FIGS. 29 and 30 illustrate an embodiment of a penetrating member slot inlongitudinal section having a ramped portion disposed at a distal end ofthe penetrating member slot and a drive member with a cutting edge at adistal end thereof for cutting through a sterility barrier during alancing cycle.

FIGS. 31-34 illustrate drive member slots in a penetrating membercartridge wherein at least a portion of the drive member slots have atapered opening which is larger in transverse dimension at the top ofthe drive member slot than at the bottom of the drive member slot.

FIGS. 35-37 illustrate an embodiment of a penetrating member cartridgeand penetrating member drive member wherein the penetrating member drivemember has a contoured jaws configured to grip a penetrating membershaft.

FIGS. 38 and 39 show a portion of a lancing device having a lid that canbe opened to expose a penetrating member cartridge cavity for removal ofa used penetrating member cartridge and insertion of a new penetratingmember cartridge.

FIGS. 40 and 41 illustrate a penetrating member cartridge that haspenetrating member slots on both sides.

FIGS. 42-44 illustrate end and perspective views of a penetrating membercartridge having a plurality of penetrating member slots formed from acorrugated surface of the penetrating member cartridge.

FIGS. 45-48 illustrate embodiments of a penetrating member and drivemember wherein the penetrating member has a slotted shaft and the drivemember has a protuberance configured to mate with the slot in thepenetrating member shaft.

FIG. 49 is a perspective view of a cartridge according to the presentinvention.

FIGS. 50 and 51 show close-ups of outer peripheries various cartridges.

FIG. 52 is a perspective view of an underside of a cartridge.

FIG. 53A shows a top down view of a cartridge and the punch and pusherdevices.

FIG. 53B is a perspective view of one embodiment of a punch plate.

FIGS. 54A-54G show a sequence of motion for the punch plate, thecartridge, and the cartridge pusher.

FIGS. 55A-55B show cross-sections of the system according to the presentinvention.

FIG. 56A shows a perspective view of the system according to the presentinvention.

FIGS. 56B-56D are cut-away views showing mechanisms within the presentinvention.

FIGS. 57-65B show optional embodiments according to the presentinvention.

FIG. 66-68 shows a still further embodiment of a cartridge according tothe present invention.

FIGS. 69A-69L show the sequence of motions associated with an optionalembodiment of a cartridge according to the present invention.

FIG. 70-72 show views of a sample modules used with still furtherembodiments of a cartridge according to the present invention.

FIG. 73 shows a cartridge with a sterility barrier and an analytedetecting member layer.

FIG. 74-78 show still further embodiments of analyte detecting memberscoupled to a cartridge.

FIGS. 79-84 show optional configurations for a cartridge for use withthe present invention.

FIG. 85 shows a see-through view of one embodiment of a system accordingto the present invention.

FIG. 86 is a schematic of an optional embodiment of a system accordingto the present invention.

FIGS. 87A-87B show still further embodiments of cartridges according tothe present invention.

FIG. 88 shows a cartridge having an array of analyte detecting members.

FIGS. 89-90 show embodiments of illumination systems for use with thepresent invention.

FIGS. 91-96 show further embodiments using optical methods for analytedetection.

FIG. 97 shows a chart of varying penetrating member velocity indifferent parts of the tissue.

FIGS. 98 and 99 show schematic views of penetrating member driversaccording to the present invention.

FIG. 100 shows a penetrating member driver according to the presentinvention for use with a cartridge containing a plurality of penetratingmembers.

FIGS. 101 and 102 show a penetrating member driver using a magneticallycontrollable fluid device.

FIGS. 103-104 show embodiments of an improved penetrating member.

FIGS. 105-109 shows a penetrating member driver using a spring and anon-spring based retractor device.

FIG. 110 shows an embodiment of a damper according to the presentinvention.

FIGS. 111-116 shows a cartridge and a penetrating member driveraccording to the present invention.

FIGS. 117 and 118 show penetrating member drivers according to thepresent invention.

FIGS. 119-120 show a depth setting device according to the presentinvention.

FIG. 121 shows a cam groove according to the present invention.

FIGS. 122-124 show various penetrating member devices according to thepresent invention.

FIGS. 125A-125B show kits according to the present invention.

FIGS. 126-129 show embodiments of the present invention according to thepresent invention using a test strip.

FIG. 130 shows one embodiment of a cartridge according to the presentinvention.

FIGS. 131 and 132 shows a top down view and side view of anotherembodiment according to the present invention.

FIGS. 133 and 135 show a still further embodiment of a cartridgeaccording to the present invention.

FIG. 136 shows a penetrating member device used with a stack of analytedetecting members.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides a multiple analyte detecting membersolution for body fluid sampling. Specifically, some embodiments of thepresent invention provides a multiple analyte detecting member andmultiple lancet solution to measuring analyte levels in the body. Theinvention may use a high density design. It may use lancets of smallersize, such as but not limited to diameter or length, than known lancets.The device may be used for multiple lancing events without having toremove a disposable from the device. The invention may provide improvedsensing capabilities. At least some of these and other objectivesdescribed herein will be met by embodiments of the present invention.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It must be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a chamber” may includemultiple chambers, and the like. References cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

“Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for analyzing ablood sample, this means that the analysis feature may or may not bepresent, and, thus, the description includes structures wherein a devicepossesses the analysis feature and structures wherein the analysisfeature is not present.

“Analyte detecting member” refers to any use, singly or in combination,of chemical test reagents and methods, electrical test circuits andmethods, physical test components and methods, optical test componentsand methods, and biological test reagents and methods to yieldinformation about a blood sample. Such methods are well known in the artand may be based on teachings of, e.g. Tietz Textbook of ClinicalChemistry, 3d Ed., Sec. V, pp. 776-78 (Burtis & Ashwood, Eds., W.B.Saunders Company, Philadelphia, 1999); U.S. Pat. No. 5,997,817 toChrismore et al. (Dec. 7, 1999); U.S. Pat. No. 5,059,394 to Phillips etal. (Oct. 22, 1991); U.S. Pat. No. 5,001,054 to Wagner et al. (Mar. 19,1991); and U.S. Pat. No. 4,392,933 to Nakamura et al. (Jul. 12, 1983),the teachings of which are hereby incorporated by reference, as well asothers. Analyte detecting member may include tests in the sample testchamber that test electrochemical properties of the blood, or they mayinclude optical means for sensing optical properties of the blood (e.g.oxygen saturation level), or they may include biochemical reagents (e.g.antibodies) to sense properties (e.g. presence of antigens) of theblood. The analyte detecting member may comprise biosensing or reagentmaterial that will react with an analyte in blood (e.g. glucose) orother body fluid so that an appropriate signal correlating with thepresence of the analyte is generated and can be read by the readerapparatus. By way of example and not limitation, analyte detectingmember may be “associated with”, “mounted within”, or “coupled to” achamber or other structure when the analyte detecting memberparticipates in the function of providing an appropriate signal aboutthe blood sample to the reader device. Analyte detecting member may alsoinclude nanowire analyte detecting members as described herein. Analytedetecting member may use any, singly or in combination, potentiometric,coulometric, or other method useful for detection of analyte levels.

FIGS. 1-11 of the accompanying drawings illustrates one embodiment of asystem 10 for piercing tissue to obtain a blood sample. The system 10may include a replaceable cartridge 12 and an apparatus 14 for removablyreceiving the cartridge 12 and for manipulating components of thecartridge 12.

Referring jointly to FIGS. 1 and 2, the cartridge 12 may include aplurality of penetrating members 18. The cartridge 12 may be in the formof a circular disc and has an outer circular surface 20 and an openingforming an inner circular surface 22. A plurality of grooves 24 areformed in a planar surface 26 of the cartridge 12. Each groove 24 iselongated and extends radially out from a center point of the cartridge12. Each groove 24 is formed through the outer circular surface 20.Although not shown, it should be understood that the grooves 24 areformed over the entire circumference of the planar surface 26. As shownin FIGS. 3 and 4, each groove 24 is relatively narrow closer to thecenter point of the cartridge 12 and slightly wider further from thecenter point. These grooves 24 may be molded into the cartridge 12,machined into the cartridge, forged, pressed, or formed using othermethods useful in the manufacture of medical devices.

In the present embodiment, each penetrating member 18 has an elongatedbody 26 and a sharpened distal end 27 having a sharp tip 30. Thepenetrating member 18 may have a circular cross-section with a diameterin this embodiment of about 0.315 mm. All outer surfaces of thepenetrating member 18 may have the same coefficient of friction. Thepenetrating member may be, but is not necessarily, a bare lancet. Thelancet is “bare”, in the sense that no raised formations or molded partsare formed thereon that are complementarily engageable with anotherstructure. Traditional lancets include large plastic molded parts thatare used to facilitate engagement. Unfortunately, such attachments addsize and cost. In the most basic sense, a bare lancet or barepenetrating member is an elongate wire having sharpened end. If it is ofsufficiently small diameter, the tip may be penetrating without havingto be sharpened. A bare lancet may be bent and still be considered abare lancet. The bare lancet in one embodiment may be made of onematerial.

In the present embodiment, each penetrating member 18 is located in arespective one of the grooves 24. The penetrating members 18 have theirsharpened distal ends 27 pointed radially out from the center point ofthe cartridge 12. A proximal end of each penetrating member 15 mayengage in an interference fit with opposing sides of a respective groove24 as shown in FIG. 3. Other embodiments of the cartridge 12 may not usesuch an interference fit. As a nonlimiting example, they may use afracturable adhesive to releasably secure the penetrating member 18 tothe cartridge 12. As shown in FIG. 4, more distal portions of thepenetrating member 18 are not engaged with the opposing sides of thegroove 24 due to the larger spacing between the sides.

The cartridge 12 may further include a sterilization barrier 28 attachedto the upper surface 26. The sterilization barrier 28 is located overthe penetrating members 18 and serves to insulate the penetratingmembers 18 from external contaminants. The sterilization barrier 28 ismade of a material that can easily be broken when an edge of a deviceapplies a force thereto. The sterilization barrier 28 alone or incombination with other barriers may be used to create a sterileenvironment about at least the tip of the penetrating member prior tolancing or actuation. The sterilization barrier 28 may be made of avariety of materials such as but not limited to metallic foil, aluminumfoil, paper, polymeric material, or laminates combining any of theabove. Other details of the sterilization barrier are detailed herein.

In the present embodiment, the apparatus 14 may include a housing 30, aninitiator button 32, a penetrating member movement subassembly 34, acartridge advance subassembly 36, batteries 38, a capacitor 40, amicroprocessor controller 42, and switches 44. The housing 30 may have alower portion 46 and a lid 48. The lid 48 is secured to the lowerportion 46 with a hinge 50. The lower portion 46 may have a recess 52. Acircular opening 54 in the lower portion 46 defines an outer boundary ofthe recess 52 and a level platform 56 of the lower portion 46 defines abase of the recess 52.

In use, the lid 48 of the present embodiment is pivoted into a positionas shown in FIG. 1. The cartridge 12 is flipped over and positioned inthe recess 52. The planar surface 26 rests against the level platform 56and the circular opening 54 contacts the outer circular surface 20 toprevent movement of the cartridge 12 in a plane thereof. The lid 48 isthen pivoted in a direction 60 and closes the cartridge 12.

Referring to the embodiment shown in FIG. 5, the penetrating membermovement subassembly 34 includes a lever 62, a penetrating memberaccelerator 64, a linear actuator 66, and a spring 68. Other suitableactuators including but not limited to rotary actuators are described incommonly assigned, copending U.S. patent application Ser. No. 10/127,395filed Apr. 19, 2002. The lever 62 may be pivotably secured to the lowerportion 46. The button 32 is located in an accessible position externalof the lower portion 46 and is connected by a shaft 70 through the lowerportion 46 to one end of the lever 62. The penetrating memberaccelerator 64 is mounted to an opposing end of the lever 62. A userdepresses the button 32 in an upward direction 66 so that the shaft 70pivots the end of the lever 62 to which it is connected in an upwarddirection. The opposing end of the lever pivots in a downward direction66. The spring 46 is positioned between the button 32 and the base 40and compresses when the button 32 is depressed to create a force thattends to move the button 32 down and pivot the penetrating memberaccelerator upward in a direction opposite to the direction 64.

Referring to FIGS. 6A and 6B in this particular embodiment, the movementof the button into the position shown in FIG. 5 also causes contactbetween a terminal 74 on the shaft 20 with a terminal 70 secured to thelower portion 46. Contact between the terminals 74 and 76 indicates thatthe button 32 has been fully depressed. With the button 32 depressed,the cartridge 12 can be rotated without interference by the penetratingmember actuator 64. To this effect, the cartridge advancer subsystem 36includes a pinion gear 80 and a stepper motor 82. The stepper motor 82is secured to the lower portion 46. The pinion gear 80 is secured to thestepper motor 82 and is rotated by the stepper motor 82. Teeth on thepinion gear 80 engage with teeth on the inner circular surface 22 of thecartridge 12. Rotation of the pinion gear 80 causes rotation of thecartridge 12 about the center point thereof. Each time that theterminals 74 and 76 make contact, the stepper motor 82 is operated torotate the cartridge 12 through a discrete angle equal to an angularspacing from a centerline of one of the penetrating members 18 to acenterline of an adjacent penetrating member. A select penetratingmember 18 is so moved over the penetrating member accelerator 64, asshown in FIG. 6B. Subsequent depressions of the button 32 will causerotation of subsequent adjacent penetrating members 18 into a positionover the penetrating member accelerator 64.

The user then releases pressure from the button, as shown in FIG. 7A.The force created by the spring 68 or other resilient member moves thebutton 32 in a downward direction 76. The shaft 70 is pivotably securedto the lever 62 so that the shaft 70 moves the end of the lever 62 towhich it is connected down. The opposite end of the lever 62 pivots thepenetrating member accelerator 64 upward in a direction 80. As shown inFIG. 7B, an edge 82 of the penetrating member accelerator 64 breaksthrough a portion of the sterilization barrier 28 and comes in tophysical contact with a lower side surface of the penetrating member 18.

Referring to FIG. 8A, the linear actuator 66 includes separate advancingcoils 86A and retracting coils 86B, and a magnetizable slug 90 withinthe coils 86A and 86B. The coils 86A and 86B are secured to the lowerportion of 46, and the slug 90 can move within the coils 86A and 88B.Once the penetrating member accelerator 64 is located in the positionshown in FIGS. 7A and 7B, electric current is provided to the advancingcoils 86 only. The current in the advancing coils 86 creates a force ina direction 88 on the slug 90 according to conventional principlesrelating to electromagnetics.

A bearing 91 is secured to the lever and the penetrating memberaccelerator 64 has a slot 92 over the bearing 91. The slot 92 allows forthe movement of the penetrating member accelerator 64 in the direction88 relative to the lever 62, so that the force created on the slug movesthe penetrating member accelerator 64 in the direction 88.

The spring 68 is not entirely relaxed, so that the spring 68, throughthe lever 62, biases the penetrating member accelerator 64 against thelower side surface of the penetrating member 18 with a force F1. Thepenetrating member 18 rests against a base 88 of the cartridge 12. Anequal and opposing force F2 is created by the base 88 on an upper sidesurface of the penetrating member 18.

The edge 82 of the penetrating member accelerator 64 has a much highercoefficient of friction than the base 88 of the cartridge 12. The highercoefficient of friction of the edge contributes to a relatively highfriction force F3 on the lower side surface of the penetrating member18. The relatively low coefficient of friction of the base 88 creates arelatively small friction force F4 on the upper side surface of thepenetrating member 18. A difference between the force F3 and F4 is aresultant force that accelerates the penetrating member in the direction88 relative to the cartridge 12. The penetrating member is moved out ofthe interference fit illustrated in FIG. 3. The bare penetrating member18 is moved without the need for any engagement formations on thepenetrating member. Current devices, in contrast, often make use aplastic body molded onto each penetrating member to aid in manipulatingthe penetrating members. Movement of the penetrating member 18 moves thesharpened end thereof through an opening 90 in a side of the lowerportion 46. The sharp end 30 of the penetrating member 18 is therebymoved from a retracted and safe position within the lower portion 46into a position wherein it extends out of the opening 90. Accelerated,high-speed movement of the penetrating member is used so that the sharptip 30 penetrates skin of a person. A blood sample can then be takenfrom the person, typically for diabetic analysis.

Reference is now made to FIGS. 9A and 9B. After the penetrating memberis accelerated (for example, but not limitation, less than 0.25 secondsthereafter), the current to the accelerating coils 86A is turned off andthe current is provided to the retracting coils 86B. The slug 90 movesin an opposite direction 92 together with the penetrating memberaccelerator 64. The penetrating member accelerator 64 then returns theused penetrating member into its original position, i.e., the same asshown in FIG. 7B.

Subsequent depression of the button as shown in FIG. 5 will then causeone repetition of the process described, but with an adjacent sterilepenetrating member. Subsequent sterile penetrating members can so beused until all the penetrating members have been used, i.e., after onecomplete revolution of the cartridge 12. In this embodiment, a secondrevolution of the cartridge 12 is disallowed to prevent the use ofpenetrating members that have been used in a previous revolution andhave become contaminated. The only way in which the user can continue touse the apparatus 14 is by opening ‘the lid 48 as shown in FIG. 1,removing the used cartridge 12, and replacing the used cartridge withanother cartridge. A detector (not shown) detects whenever a cartridgeis removed and replaced with another cartridge. Such a detector may bebut is not limited to an optical sensor, an electrical contact sensor, abar code reader, or the like.

FIG. 10 illustrates the manner in which the electrical components may befunctionally interconnected for the present embodiment. The battery 38provides power to the capacitor 40 and the controller 42. The terminal76 is connected to the controller 42 so that the controller recognizeswhen the button 32 is depressed. The capacitor to provide power(electric potential and current) individually through the switches (suchas field-effect transistors) to the advancing coils 86A, retractingcoils 86B and the stepper motor 82. The switches 44A, B, and C are allunder the control of the controller 42. A memory 100 is connected to thecontroller. A set of instructions is stored in the memory 100 and isreadable by the controller 42. Further functioning of the controller 42in combination with the terminal 76 and the switches 44A, B, and Cshould be evident from the foregoing description.

FIG. 11 illustrates a configuration for another embodiment of acartridge having penetrating members. The cartridge 112 has a corrugatedconfiguration and a plurality of penetrating members 118 in grooves 124formed in opposing sides of the cartridge 112. Sterilization barriers126 and 128 are attached over the penetrating members 118 at the top andthe penetrating members 118 at the bottom, respectively. Such anarrangement provides large surfaces for attachment of the sterilizationbarriers 126 and 128. All the penetrating members 118 on the one sideare used first, whereafter the cartridge 112 is turned over and thepenetrating members 118 on the other side are used. Additional aspectsof such a cartridge are also discussed in FIGS. 42-44.

Referring now to FIGS. 12-13, a friction based method of coupling withand driving bare lancets or bare penetrating members will be describedin further detail. Any embodiment of the present invention disclosedherein may be adapted to use these methods. As seen in FIG. 12, surface201 is physically in contact with penetrating member 202. Surface 203 isalso physically in contact with penetrating member 202. In the presentembodiment of the invention, surface 201 is stainless steel, penetratingmember 202 is stainless steel, and surface 203 ispolytetrafluoroethylene-coated stainless steel.

FIG. 13 illustrates one embodiment of the friction based coupling inuse. Normal force 206 may be applied vertically to surface 201, pressingit against penetrating member 202. Penetrating member 202 is therebypressed against surface 203. Normal force 206 is transmitted throughsurface 201 and penetrating member 202 to also act between penetratingmember 202 and surface 203. Surface 203 is held rigid or stationary withrespect to a target of the lancet. Using the classical static frictionmodel, the maximum frictional force between surface 201 and penetratingmember 202 is equal to the friction coefficient between surface 201 andpenetrating member 202 multiplied by the normal force between surface201 and penetrating member 202. In this embodiment, the maximumfrictional force between surface 203 and penetrating member 202 is equalto the coefficient of friction between the surface 203 and thepenetrating member 202 multiplied by the normal force between thesurface 203 and the penetrating member 202. Because friction coefficientbetween surface 203 and penetrating member 202 is less than frictioncoefficient between surface 201 and penetrating member 202, theinterface between surface 201 and penetrating member 202 can develop ahigher maximum static friction force than can the interface betweensurface 203 and penetrating member 202.

Driving force as indicated by arrow 207 is applied to surface 201perpendicular to normal force 206. The sum of the forces actinghorizontally on surface 201 is the sum of driving force 207 and thefriction force developed at the interface of surface 201 and penetratingmember 202, which acts in opposition to driving force 207. Since thecoefficient of friction between surface 203 and penetrating member 202is less than the coefficient of friction between surface 201 andpenetrating member 202, penetrating member 202 and surface 201 willremain stationary with respect to each other and can be considered tobehave as one piece when driving force 207 just exceeds the maximumfrictional force that can be supported by the interface between surface203 and penetrating member 202. Surface 201 and penetrating member 202can be considered one piece because the coefficient of friction betweensurface 201 and penetrating member 202 is high enough to preventrelative motion between the two.

In one embodiment, the coefficient of friction between surface 201 andpenetrating member 202 is approximately 0.8 corresponding to thecoefficient of friction between two surfaces of stainless steel, whilethe coefficient of friction between surface 203 and penetrating member202 is approximately 0.04, corresponding to the coefficient of frictionbetween a surface of stainless steel and one of polytetrafluoroethylene.Normal force 206 has a value of 202 Newtons. Using these values, themaximum frictional force that the interface between surface 201 andpenetrating member 202 can support is 1.6 Newtons, while the maximumfrictional force that the interface between surface 203 and penetratingmember 202 can support is 0.08 Newtons. If driving force 207 exceeds0.08 Newtons, surface 201 and penetrating member 202 will begin toaccelerate together with respect to surface 203. Likewise, if drivingforce 207 exceeds 1.6 Newtons and penetrating member 202 encounters arigid barrier, surface 201 would move relative to penetrating member202.

Another condition, for example, for surface 201 to move relative topenetrating member 202 would be in the case of extreme acceleration. Inan embodiment, penetrating member 202 has a mass of 8.24×10-6 kg. Anacceleration of 194,174 m/s2 of penetrating member 202 would thereforebe required to exceed the frictional force between penetrating member202 and surface 201, corresponding to approximately 19,800 g's. Withoutbeing bound to any particular embodiment or theory of operation, othermethods of applying friction base coupling may also be used. Forexample, the penetrating member 202 may be engaged by a coupler using ainterference fit to create the frictional engagement with the member.

FIG. 14 illustrates a polytetrafluoroethylene coating on stainless steelsurface 203 in detail. It should be understood that the surface 203 maybe coated with other materials such as but not limited to Telfon®,silicon, polymer or glass. The coating may cover all of the penetratingmember, only the proximal portions, only the distal portions, only thetip, only some other portion, or some combination of some or all of theabove. FIG. 15 illustrates a doping of lead applied to surface 201,which conforms to penetrating member 202 microscopically when pressedagainst it. Both of these embodiments and other coated embodiments of apenetrating member may be used with the actuation methods describedherein.

The shapes and configurations of surface 201 and surface 102 could besome form other than shown in FIGS. 12-15. For example, surface 201could be the surface of a wheel, which when rotated causes penetratingmember 202 to advance or retract relative to surface 203. Surface 201could be coated with another conformable material besides lead, such asa plastic. It could also be coated with particles, such as diamond dust,or given a surface texture to enhance the friction coefficient ofsurface 201 with penetrating member 202. Surface 202 could be made of orcoated with diamond, fluorinated ethylene propylene, perfluoroalkoxy, acopolymer of ethylene and tetrafluoroethylene, a copolymer of ethyleneand chlorotrifluoroethylene, or any other material with a coefficient offriction with penetrating member 202 lower than that of the materialused for surface 201.

Referring to FIG. 16, a portion of a base plate 210 of an embodiment ofa penetrating member cartridge is shown with a plurality of penetratingmember slots 212 disposed in a radial direction cut into a top surface214 of the base plate. A drive member 216 is shown with a distal edge218 disposed within one of the penetrating member slots 212 of the baseplate 210. The distal edge 218 of the drive member 216 is configured toslide within the penetrating member slots 212 with a minimum of frictionbut with a close fit to minimize lateral movement during a lancingcycle.

FIG. 17 shows a distal portion 220 of a coated penetrating member 222 inpartial longitudinal section. The coated penetrating member 222 has acore portion 224, a coating 226 and a tapered distal end portion 228. Aportion of a coated drive member 230 is shown having a coating 234 withpenetrating member contact surface 236. The penetrating member contactsurface 236 forms an interface 238 with an outer surface 240 of thecoated penetrating member 222. The interface 238 has a characteristicfriction coefficient that will depend in part on the choice of materialsfor the penetrating member coating 226 and the drive member coating 234.If silver is used as the penetrating member and drive member coating 226and 236, this yields a friction coefficient of about 1.3 to about 1.5.Other materials can be used for coatings 226 and 236 to achieve thedesired friction coefficient. For example, gold, platinum, stainlesssteel and other materials may be used for coatings 226 and 236. It maybe desirable to use combinations of different materials for coatings 226and 236. For example, an embodiment may include silver for a penetratingmember coating 226 and gold for a drive member coating. Some embodimentsof the interface 238 can have friction coefficients of about 1.15 toabout 5.0, specifically, about 1.3 to about 2.0.

Embodiments of the penetrating member 222 can have an outer transversedimension or diameter of about 200 to about 400 microns, specifically,about 275 to about 325 microns. Embodiments of penetrating member 222can have a length of about 10 to about 30 millimeters, specifically,about 15 to about 25 millimeters. Penetrating member 222 can be madefrom any suitable high strength alloy such as stainless steel or thelike.

FIG. 18 is a perspective view of a lancing device 242 having features ofthe invention. A penetrating member cartridge 244 is disposed about adriver 246 that is coupled to a drive member 248 by a coupler rod 250.The penetrating member cartridge 244 has a plurality of penetratingmember slots 252 disposed in a radial configuration in a top surface 254a base plate 256 of the penetrating member cartridge 244. The distalends 253 of the penetrating member slots 252 are disposed at an outersurface 260 of the base plate 256. A fracturable sterility barrier 258,shown partially cut away, is disposed on the top surface 254 of baseplate 256 over the plurality of penetrating member slots 252. Thesterility barrier 258 is also disposed over the outer surface 260 of thebase plate 256 in order to seal the penetrating member slots fromcontamination prior to a lancing cycle. A distal portion of apenetrating member 262 is shown extending radially from the penetratingmember cartridge 244 in the direction of a patient's finger 264.

FIG. 19 illustrates a portion of the base plate 256 used with thelancing device 242 in more detail and without sterility barrier 258 inplace (for ease of illustration). The base plate 256 includes aplurality of penetrating member slots 252 which are in radial alignmentwith corresponding drive member slots 266. The drive member slots 266have an optional tapered input configuration that may facilitatealignment of the drive member 248 during downward movement into thedrive member slot 266 and penetrating member slot 252. Penetratingmember slots 252 are sized and configured to accept a penetrating member262 disposed therein and allow axial movement of the penetrating member262 within the penetrating member slots 252 without substantial lateralmovement.

Referring again to FIG. 18, in use, the present embodiment ofpenetrating member cartridge 242 is placed in an operationalconfiguration with the driver 246. A lancing cycle is initiated and thedrive member 248 is brought down through the sterility barrier 258 andinto a penetrating member slot 252. A penetrating member contact surfaceof the drive member then makes contact with an outside surface of thepenetrating member 262 and is driven distally toward the patient'sfinger 264 as described above with regard to the embodiment discussed inFIG. 20. The friction coefficient between the penetrating member contactsurface of the drive member 248 and the penetrating member 262 isgreater than the friction coefficient between the penetrating member 262and an interior surface of the penetrating member slots 252. As such,the drive member 248 is able to drive the penetrating member 262distally through the sterility barrier 258 and into the patient's finger264 without any relative movement or substantial relative movementbetween the drive member 248 and the penetrating member 262.

Referring to FIGS. 20-22, a lancing cycle sequence is shown for alancing device 242 with another embodiment of a penetrating membercartridge 244 as shown in FIGS. 23 and 24. The base plate 256 of thepenetrating member cartridge 242 shown in FIGS. 23 and 24 has aplurality of penetrating member slots 252 with top openings 268 that donot extend radially to the outer surface 260 of the base plate 256. Inthis way, the penetrating member slots 252 can be sealed with a firststerility barrier 270 disposed on the top surface 254 of the base plate256 and a second sterility barrier 272 disposed on the outer surface 260of the base plate 256. Penetrating member outlet ports 274 are disposedat the distal ends of the penetrating member slots 252.

Referring again to FIG. 20, the penetrating member 262 is shown in theproximally retracted starting position within the penetrating memberslot 252. The outer surface of the penetrating member 276 is in contactwith the penetrating member contact surface 278 of the drive member 248.The friction coefficient between the penetrating member contact surface278 of the drive member 248 and the outer surface 276 of the penetratingmember 262 is greater than the friction coefficient between thepenetrating member 262 and an interior surface 280 of the penetratingmember slots 252. A distal drive force as indicated by arrow 282 in FIG.10 is then applied via the drive coupler 250 to the drive member 248 andthe penetrating member is driven out of the penetrating member outletport 274 and into the patient's finger 264. A proximal retraction force,as indicated by arrow 284 in FIG. 22, is then applied to the drivemember 248 and the penetrating member 262 is withdrawn from thepatient's finger 264 and back into the penetrating member slot 252.

FIGS. 25 and 26 illustrate an embodiment of a multiple layer sterilitybarrier 258 in the process of being penetrated by a penetrating member62. It should be understood that this barrier 258 may be adapted for usewith any embodiment of the present invention. The sterility barrier 258shown in FIGS. 25 and 26 is a two layer sterility barrier 258 thatfacilitates maintaining sterility of the penetrating member 262 as itpasses through and exits the sterility barrier 258. In FIG. 25, thedistal end 286 of the penetrating member 262 is applying an axial forcein a distal direction against an inside surface 288 of a first layer 290of the sterility barrier 258, so as to deform the first layer 290 of thesterility barrier 258. The deformation 291 of the first layer 290 inturn applies a distorting force to the second layer 292 of the sterilitybarrier 258. The second layer of the sterility barrier is configured tohave a lower tensile strength that the first layer 290. As such, thesecond layer 292 fails prior to the first layer 290 due to the strainimposed on the first layer 290 by the distal end 286 of the penetratingmember 262, as shown in FIG. 26. After the second layer 292 fails, itthen retracts from the deformed portion 291 of the first layer 290 asshown by arrows 294 in FIG. 26. As long as the inside surface 288 andoutside surface 296 of the first layer 290 are sterile prior to failureof the second layer 292, the penetrating member 262 will remain sterileas it passes through the first layer 290 once the first layer eventuallyfails. Such a multiple layer sterility barrier 258 can be used for anyof the embodiments discussed herein. The multiple layer sterilitybarrier 258 can also include three or more layers.

Referring to FIGS. 27 and 28, an embodiment of a drive member 300coupled to a driver 302 wherein the drive member 300 includes a cuttingmember 304 having a sharpened edge 306 which is configured to cutthrough a sterility barrier 258 of a penetrating member slot 252 duringa lancing cycle in order for the drive member 300 to make contact with apenetrating member. An optional lock pin 308 on the cutting member 304can be configured to engage the top surface 310 of the base plate inorder to prevent distal movement of the cutting member 304 with thedrive member 300 during a lancing cycle.

FIGS. 29 and 30 illustrate an embodiment of a penetrating member slot316 in longitudinal section having a ramped portion 318 disposed at adistal end 320 of the penetrating member slot. A drive member 322 isshown partially disposed within the penetrating member slot 316. Thedrive member 322 has a cutting edge 324 at a distal end 326 thereof forcutting through a sterility barrier 328 during a lancing cycle. FIG. 30illustrates the cutting edge 324 cutting through the sterility barrier328 during a lancing cycle with the cut sterility barrier 328 peelingaway from the cutting edge 324.

FIGS. 31-34 illustrate drive member slots in a base plate 330 of apenetrating member cartridge wherein at least a portion of the drivemember slots have a tapered opening which is larger in transversedimension at a top surface of the base plate than at the bottom of thedrive member slot. FIG. 31 illustrates a base plate 330 with apenetrating member slot 332 that is tapered at the input 334 at the topsurface 336 of the base plate 330 along the entire length of thepenetrating member slot 332. In such a configuration, the penetratingmember slot and drive member slot (not shown) would be in communicationand continuous along the entire length of the slot 332. As an optionalalternative, a base plate 338 as shown in FIGS. 32 and 33 can have adrive member slot 340 that is axially separated from the correspondingpenetrating member slot 342. With this configuration, the drive memberslot 340 can have a tapered configuration and the penetrating memberslot 342 can have a straight walled configuration. In addition, thisconfiguration can be used for corrugated embodiments of base plates 346as shown in FIG. 34. In FIG. 34, a drive member 348 is disposed within adrive member slot 350. A penetrating member contact surface 352 isdisposed on the drive member 348. The contact surface 352 has a taperedconfiguration that will facilitate lateral alignment of the drive member348 with the drive member slot 350.

FIGS. 35-37 illustrate an embodiment of a penetrating member cartridge360 and drive member 362 wherein the drive member 362 has contoured jaws364 configured to grip a penetrating member shaft 366. In FIG. 35, thedrive member 362 and penetrating member shaft 366 are shown intransverse cross section with the contoured jaws 364 disposed about thepenetrating member shaft 366. A pivot point 368 is disposed between thecontoured jaws 364 and a tapered compression slot 370 in the drivemember 362. A compression wedge 372 is shown disposed within the taperedcompression slot 370. Insertion of the compression wedge 372 into thecompression slot 370 as indicated by arrow 374, forces the contouredjaws 364 to close about and grip the penetrating member shaft 366 asindicated by arrows 376.

FIG. 36 shows the drive member 362 in position about a penetratingmember shaft 366 in a penetrating member slot 378 in the penetratingmember cartridge 360. The drive member can be actuated by the methodsdiscussed above with regard to other drive member and driverembodiments. FIG. 37 is an elevational view in longitudinal section ofthe penetrating member shaft 166 disposed within the penetrating memberslot 378. The arrows 380 and 382 indicate in a general way, the pathfollowed by the drive member 362 during a lancing cycle. During alancing cycle, the drive member comes down into the penetrating memberslot 378 as indicated by arrow 380 through an optional sterility barrier(not shown). The contoured jaws of the drive member then clamp about thepenetrating member shaft 366 and move forward in a distal direction soas to drive the penetrating member into the skin of a patient asindicated by arrow 382.

FIGS. 38 and 39 show a portion of a lancing device 390 having a lid 392that can be opened to expose a penetrating member cartridge cavity 394for removal of a used penetrating member cartridge 396 and insertion ofa new penetrating member cartridge 398. Depression of button 400 in thedirection indicated by arrow 402 raises the drive member 404 from thesurface of the penetrating member cartridge 396 by virtue of leveraction about pivot point 406. Raising the lid 392 actuates the lever arm408 in the direction indicated by arrow 410 which in turn applies atensile force to cable 412 in the direction indicated by arrow 414. Thisaction pulls the drive member back away from the penetrating membercartridge 396 so that the penetrating member cartridge 396 can beremoved from the lancing device 390. A new penetrating member cartridge398 can then be inserted into the lancing device 390 and the steps abovereversed in order to position the drive member 404 above the penetratingmember cartridge 398 in an operational position.

FIGS. 40 and 41 illustrate a penetrating member cartridge 420 that haspenetrating member slots 422 on a top side 424 and a bottom side 426 ofthe penetrating member cartridge 420. This allows for a penetratingmember cartridge 420 of a diameter D to store for use twice the numberof penetrating members as a one sided penetrating member cartridge ofthe same diameter D.

FIGS. 42-44 illustrate end and perspective views of a penetrating membercartridge 430 having a plurality of penetrating member slots 432 formedfrom a corrugated surface 434 of the penetrating member cartridge 430.Penetrating members 436 are disposed on both sides of the penetratingmember cartridge 430. A sterility barrier 438 is shown disposed over thepenetrating member slots 432 in FIG. 44.

FIGS. 45-48 illustrate embodiments of a penetrating member 440 and drivemember 442 wherein the penetrating member 440 has a transverse slot 444in the penetrating member shaft 446 and the drive member 442 has aprotuberance 448 configured to mate with the transverse slot 444 in thepenetrating member shaft 446. FIG. 45 shows a protuberance 448 having atapered configuration that matches a tapered configuration of thetransverse slot 444 in the penetrating member shaft 446. FIG. 46illustrates an optional alternative embodiment wherein the protuberance448 has straight walled sides that are configured to match the straightwalled sides of the transverse slot 444 shown in FIG. 46. FIG. 47 showsa tapered protuberance 448 that is configured to leave an end gap 450between an end of the protuberance 448 and a bottom of the transverseslot in the penetrating member shaft 446.

FIG. 48 illustrates a mechanism 452 to lock the drive member 442 to thepenetrating member shaft 446 that has a lever arm 454 with an optionalbearing 456 on the first end 458 thereof disposed within a guide slot459 of the drive member 442. The lever arm 454 has a pivot point 460disposed between the first end 458 of the lever arm 454 and the secondend 462 of the lever arm 454. A biasing force is disposed on the secondend 462 of the lever arm 454 by a spring member 464 that is disposedbetween the second end 462 of the lever arm 454 and a base plate 466.The biasing force in the direction indicated by arrow 468 forces thepenetrating member contact surface 470 of the drive member 442 againstthe outside surface of the penetrating member 446 and, in addition,forces the protuberance 448 of the drive member 442 into the transverseslot 444 of the penetrating member shaft 446.

Referring now to FIG. 49, another embodiment of a replaceable cartridge500 suitable for housing a plurality of individually moveablepenetrating members (not shown) will be described in further detail.Although cartridge 500 is shown with a chamfered outer periphery, itshould also be understood that less chamfered and unchamferedembodiments of the cartridge 500 may also be adapted for use with anyembodiment of the present invention disclosed herein. The penetratingmembers slidably coupled to the cartridge may be a bare lancet or bareelongate member without outer molded part or body pieces as seen inconventional lancet. The bare design reduces cost and simplifiesmanufacturing of penetrating members for use with the present invention.The penetrating members may be retractable and held within the cartridgeso that they are not able to be used again. The cartridge is replaceablewith a new cartridge once all the piercing members have been used. Thelancets or penetrating members may be fully contained in the usedcartridge so at to minimize the chance of patient contact with suchwaste.

As can be seen in FIG. 49, the cartridge 500 may include a plurality ofcavities 501 for housing a penetrating member. In this embodiment, thecavity 501 may have a longitudinal opening 502 associated with thecavity. The cavity 501 may also have a lateral opening 503 allowing thepenetrating member to exit radially outward from the cartridge. As seenin FIG. 49, the outer radial portion of the cavity may be narrowed. Theupper portion of this narrowed area may also be sealed or swaged toclose the top portion 505 and define an enclosed opening 506 as shown inFIG. 50. Optionally, the narrowed area 504 may retain an open topconfiguration, though in some embodiments, the foil over the gap isunbroken, preventing the penetrating member from lifting up or extendingupward out of the cartridge. The narrowed portion 504 may act as abearing and/or guide for the penetrating member. FIG. 51 shows that theopening 506 may have a variety of shapes such as but not limited to,circular, rectangular, triangular, hexagonal, square, or combinations ofany or all of the previous shapes. Openings 507 (shown in phantom) forother microfluidics, capillary tubes, or the like may also beincorporated in the immediate vicinity of the opening 506. In someoptional embodiments, such openings 507 may be configured to surroundthe opening 506 in a concentric or other manner.

Referring now to FIG. 52, the underside of a cartridge 500 will bedescribed in further detail. This figures shows many features on onecartridge 500. It should be understood that a cartridge may includesome, none, or all of these features, but they are shown in FIG. 52 forease of illustration. The underside may include indentations or holes510 close to the inner periphery for purpose of properly positioning thecartridge to engage a penetrating member gripper and/or to allow anadvancing device (shown in FIGS. 56B and 56C) to rotate the cartridge500. Indentations or holes 511 may be formed along various locations onthe underside of cartridge 500 and may assume various shapes such as butnot limited to, circular, rectangular, triangular, hexagonal, square, orcombinations of any or all of the previous shapes. Notches 512 may alsobe formed along the inner surface of the cartridge 500 to assist inalignment and/or rotation of the cartridge. It should be understood ofcourse that some of these features may also be placed on the topside ofthe cartridge in areas not occupied by cavities 501 that house thepenetrating members. Notches 513 may also be incorporated along theouter periphery of the cartridge. These notches 513 may be used togather excess material from the sterility barrier 28 (not shown) thatmay be used to cover the angled portion 514 of the cartridge. In thepresent embodiment, the cartridge has a flat top surface and an angledsurface around the outside. Welding a foil type sterility barrier overthat angled surface, the foil folds because of the change in thesurfaces which is now at 45 degrees. This creates excess material. Thegrooves or notches 513 are there as a location for that excess material.Placing the foil down into those grooves 513 which may tightly stretchthe material across the 45 degree angled surface. Although in thisembodiment the surface is shown to be at 45 degrees, it should beunderstood that other angles may also be used. For example, the surfacemay be at any angle between about 3 degrees to 90 degrees, relative tohorizontal. The surface may be squared off. The surface may beunchamfered. The surface may also be a curved surface or it may becombinations of a variety of angled surfaces, curved and straightssurfaces, or any combination of some or all of the above.

Referring now to FIGS. 53-54, the sequence in which the cartridge 500 isindexed and penetrating members are actuated will now be described. Itshould be understood that some steps described herein may be combined ortaken out of order without departing from the spirit of the invention.These sequence of steps provides vertical and horizontal movement usedwith the present embodiment to load a penetrating member onto thedriver.

As previously discussed, each cavity on the cartridge may beindividually sealed with a foil cover or other sterile enclosurematerial to maintain sterility until or just before the time of use. Inthe present embodiment, penetrating members are released from theirsterile environments just prior to actuation and are loaded onto alauncher mechanism for use. Releasing the penetrating member from thesterile environment prior to launch allows the penetrating member in thepresent embodiment to be actuated without having to pierce any sterileenclosure material which may dull the tip of the penetrating member orplace contaminants on the member as it travels towards a target tissue.A variety of methods may be used accomplish this goal.

FIG. 53A shows one embodiment of penetrating member release device,which in this embodiment is a punch plate 520 that is shown in asee-through depiction for ease of illustration. The punch plate 520 mayinclude a first portion 521 for piercing sterile material covering thelongitudinal opening 502 and a second portion 522 for piercing materialcovering the lateral opening 503. A slot 523 allows the penetratingmember gripper to pass through the punch plate 520 and engage apenetrating member housed in the cartridge 500. The second portion 522of the punch plate down to engage sterility barrier angled at about a 45degree slope. Of course, the slope of the barrier may be varied. Thepunch portion 522 first contacts the rear of the front pocket sterilitybarrier and as it goes down, the cracks runs down each side and thebarrier is pressed down to the bottom of the front cavity. The rear edgeof the barrier first contacted by the punch portion 522 is broken offand the barrier is pressed down, substantially cleared out of the way.These features may be more clearly seen in FIG. 53B. The punch portion521 may include a blade portion down the centerline. As the punch comesdown, that blade may be aligned with the center of the cavity, cuttingthe sterility barrier into two pieces. The wider part of the punch 521then pushes down on the barrier so the they align parallel to the sidesof the cavity. This creates a complete and clear path for the gripperthroughout the longitudinal opening of the cavity. Additionally, as seenin FIGS. 53B and 54A, a plurality of protrusion 524 are positioned toengage a cam (FIG. 55A) which sequences the punching and other verticalmovement of punch plate 520 and cartridge pusher 525. The drive shaft526 from a force generator (not shown) which is used to actuate thepenetrating member 527.

Referring now to FIGS. 54A-F, the release and loading of the penetratingmembers are achieved in the following sequence. FIG. 54A shows therelease and loading mechanism in rest state with a dirty barepenetrating member 527 held in a penetrating member gripper 530. This isthe condition of the device between lancing events. When the time comesfor the patient to initiate another lancing event, the used penetratingmember is cleared and a new penetrating member is loaded, just prior tothe actual lancing event. The patient begins the loading of a newpenetrating member by operating a setting lever to initiate the process.The setting lever may operate mechanically to rotate a cam (see FIG.55A) that moves the punch plate 520 and cartridge pusher 525. In otherembodiments, a stepper motor or other mover such as but not limited to,a pneumatic actuator, hydraulic actuator, or the like are used to drivethe loading sequence.

FIG. 54B shows one embodiment of penetrating member gripper 530 in moredetail. The penetrating member gripper 530 may be in the form of atuning fork with sharp edges along the inside of the legs contacting thepenetrating member. In some embodiments, the penetrating member may benotched, recessed, or otherwise shaped to receive the penetrating membergripper. As the gripper 530 is pushed down on the penetrating member,the legs are spread open elastically to create a frictional grip withthe penetrating member such as but not limited to bare elongate wireswithout attachments molded or otherwise attached thereon. In someembodiments, the penetrating member is made of a homogenous materialwithout any additional attachments that are molded, adhered, glued orotherwise added onto the penetrating member.

In some embodiments, the gripper 530 may cut into the sides of thepenetrating member. The penetrating member in one embodiment may beabout 300 microns wide. The grooves that form in the side of thepenetrating member by the knife edges are on the order of about 5-10microns deep and are quite small. In this particular embodiment, theknife edges allow the apparatus to use a small insertion force to getthe gripper onto the penetrating member, compared to the force to removethe penetrating member from the gripper the longitudinal axis of anelongate penetrating member. Thus, the risk of a penetrating memberbeing detached during actuation are reduced. The gripper 530 may be madeof a variety of materials such as, but not limited to high strengthcarbon steel that is heat treated to increased hardness, ceramic,substrates with diamond coating, composite reinforced plastic,elastomer, polymer, and sintered metals. Additionally, the steel may besurface treated. The gripper 130 may have high gripping force with lowfriction drag on solenoid or other driver.

As seen in FIG. 54C, the sequence begins with punch plate 520 beingpushed down. This results in the opening of the next sterile cavity 532.In some embodiment, this movement of punch plate 520 may also result inthe crimping of the dirty penetrating member to prevent it from beingused again. This crimping may result from a protrusion on the punchplate bending the penetrating member or pushing the penetrating memberinto a groove in the cartridge that hold the penetrating member in placethrough an interference fit. As seen in FIGS. 53B and 54C, the punchplate 520 has a protrusion or punch shaped to penetrate a longitudinalopening 502 and a lateral opening 503 on the cartridge. The firstportion 521 of the punch that opens cavity 532 is shaped to first piercethe sterility barrier and then push, compresses, or otherwise movessterile enclosure material towards the sides of the longitudinal opening502. The second portion 522 of the punch pushes down the sterilitybarrier at lateral opening or penetrating member exit 503 such that thepenetrating member does not pierce any materials when it is actuatedtoward a tissue site.

Referring now to FIG. 54D, the cartridge pusher 525 is engaged by thecam 550 (not shown) and begins to push down on the cartridge 500. Thepunch plate 520 may also travel downward with the cartridge 500 until itis pushed down to it maximum downward position, while the penetratingmember gripper 530 remains vertically stationary. This joint downwardmotion away from the penetrating member gripper 530 will remove thepenetrating member from the gripper. The punch plate 520 essentiallypushes against the penetrating member with protrusion 534 (FIG. 55A),holding the penetrating member with the cartridge, while the cartridge500 and the punch plate 520 is lowered away from the penetrating membergripper 530 which in this embodiment remains vertically stationary. Thiscauses the stripping of the used penetrating member from the gripper 530(FIG. 45D) as the cartridge moves relative to the gripper.

At this point as seen in FIG. 54E, the punch plate 520 retracts upwardand the cartridge 500 is pushed fully down, clear of the gripper 530.Now cleared of obstructions and in a rotatable position, the cartridge500 increments one pocket or cavity in the direction that brings thenewly released, sterile penetrating member in cavity 532 into alignmentwith the penetrating member gripper 530, as see in FIG. 54F. Therotation of the cartridge occurs due to fingers engaging the holes orindentations 533 on the cartridge, as seen in FIG. 54A. In someembodiments, these indentations 533 do not pass completely throughcartridge 500. In other embodiments, these indentations are holespassing completely through. The cartridge has a plurality of littleindentations 533 on the top surface near the center of the cartridge,along the inside diameter. In the one embodiment, the sterility barrieris cut short so as not to cover these plurality of indentations 533. Itshould be understood of course that these holes may be located onbottom, side or other accessible surface. These indentations 533 havetwo purposes. The apparatus may have one or a plurality of locator pins,static pins, or other keying feature that dos not move. In thisembodiment, the cartridge will only set down into positions where thegripper 530 is gripping the penetrating member. To index the cassette,the cartridge is lifted off those pins or other keyed feature, rotatedaround, and dropped onto those pins for the next position. The rotatingdevice is through the use of two fingers: one is a static pawl and theother one is a sliding finger. They engage with the holes 533. Thefingers are driven by a slider that may be automatically actuated oractuated by the user. This maybe occur mechanically or through electricor other powered devices. Halfway through the stroke, a finger mayengage and rotate around the cartridge. A more complete description canbe found with text associated with FIGS. 56B-56C.

Referring now to FIG. 54G, with the sterile penetrating member inalignment, the cartridge 500 is released as indicated by arrows 540 andbrought back into contact with the penetrating member gripper 530. Thenew penetrating member 541 is inserted into the gripper 530, and theapparatus is ready to fire once again. After launch and in betweenlancing events for the present embodiment, the bare lancet orpenetrating member 541 is held in place by gripper 530, preventing thepenetrating member from accidentally protruding or sliding out of thecartridge 500.

It should be understood of course, that variations can be added to theabove embodiment without departing from the spirit of the invention. Forexample, the penetrating member 541 may be placed in a parked positionin the cartridge 500 prior to launch. As seen in FIG. 55A, thepenetrating member is held by a narrowed portion 542 of the cartridge,creating an interference fit which pinches the proximal end of thepenetrating member. Friction from the molding or cartridge holds thepenetrating member during rest, preventing the penetrating member fromsliding back and forth. Of course, other methods of holding thepenetrating member may also be used. As seen in FIG. 55B prior tolaunch, the penetrating member gripper 530 may pull the penetratingmember 541 out of the portion 542. The penetrating member 541 may remainin this portion until actuated by the solenoid or other force generatorcoupled to the penetrating member gripper. A cam surface 544 may be usedto pull the penetrating member out of the portion 542. This mechanicalcam surface may be coupled to the mechanical slider driven by thepatient, which may be considered a separate force generator. Thus,energy from the patient extracts the penetrating member and this reducesthe drain on the device's battery if the solenoid or electric driverwere to pull out the penetrating member. The penetrating member may bemoved forward a small distance (on the order of about 1 mm or less) fromits parked position to pull the penetrating member from the restposition gripper. After penetrating tissue, the penetrating member maybe returned to the cartridge and eventually placed into the parkedposition. This may also occur, though not necessarily, through forceprovided by the patient. In one embodiment, the placing of the lancetinto the parked position does not occur until the process for loading anew penetrating member is initiated by the patient. In otherembodiments, the pulling out of the parked position occurs in the samemotion as the penetrating member actuation. The return into the parkedposition may also be considered a continuous motion.

FIG. 55A also shows one embodiment of the cam and other surfaces used tocoordinate the motion of the punch plate 520. For example, cam 550 inthis embodiment is circular and engages the protrusions 524 on the punchplate 520 and the cartridge pusher 525. FIG. 55A also more clearly showsprotrusion 534 which helps to hold the penetrating member in thecartridge 500 while the penetrating member gripper 530 pulls away fromthe member, relatively speaking. A ratchet surface 552 that rotates withthe cam 550 may be used to prevent the cam from rotating backwards. Theraising and lower of cartridge 500 and punch plate 50 used toload/unload penetrating members may be mechanically actuated by avariety of cam surfaces, springs, or the like as may be determined byone skilled in the art. Some embodiments may also use electrical ormagnetic device to perform the loading, unloading, and release of barepenetrating members. Although the punch plate 520 is shown to bepunching downward to displace, remove, or move the foil or other sterileenvironment enclosure, it should be understood that other methods suchas stripping, pulling, tearing, or some combination of one or more ofthese methods may be used to remove the foil or sterile enclosure. Forexample, in other embodiments, the punch plate 520 may be located on anunderside of the cartridge and punch upward. In other embodiments, thecartridge may remain vertically stationary while other parts such as thepenetrating member gripper and punch plate move to load a sterilepenetrating member on to the penetrating member gripper.

FIG. 55B also shows other features that may be included in the presentapparatus. A fire button 560 may be included for the user to actuate thepenetrating member. A front end interface 561 may be included to allow apatient to seat their finger or other target tissue for lancing. Theinterface 561 may be removable to be cleaned or replaced. A visualdisplay 562 may be included to show device status, lancing performance,error reports, or the like to the patient.

Referring now to FIG. 56A, a mechanical slider 564 used by the patientto load new penetrating member may also be incorporated on the housing.The slider 564 may also be coupled to activate an LCD or visual displayon the lancing apparatus. In addition to providing a source of energy toindex the cartridge, the slider 564 may also switch the electronics tostart the display. The user may use the display to select the depth oflancing or other feature. The display may go back to sleep again untilit is activated again by motion of the slider 564. The underside thehousing 566 may also be hinged or otherwise removable to allow theinsertion of cartridge 500 into the device. The cartridge 500 may beinserted using technology current used for insertion of a compact discor other disc into a compact disc player. In one embodiment, there maybe a tray which is deployed outward to receive or to remove a cartridge.The tray may be withdrawn into the apparatus where it may be elevated,lowered, or otherwise transported into position for use with thepenetrating member driver. In other embodiments, the apparatus may havea slot into which the cartridge is partially inserted at which point amechanical apparatus will assist in completing insertion of thecartridge and load the cartridge into proper position inside theapparatus. Such device is akin to the type of compact disc player foundon automobiles. The insertions/ejection and loading apparatus of thesecompact disc players uses gears, pulleys, cables, trays, and/or otherparts that may be adapted for use with the present invention.

Referring now to FIG. 56B, a more detailed view of one embodiment of theslider 564 is provided. In this embodiment, the slider 564 will moveinitially as indicated by arrow 567. To complete the cycle, the patientwill return the slider to its home position or original startingposition as indicated by arrow 568. The slider 564 has an arm 569 whichmoves with the slider to rotate the cam 550 and engage portions 522. Themotion of the slider 564 is also mechanically coupled to a finger 570which engage the indentations 571 on cartridge 500. The finger 570 issynchronized to rotate the cartridge 500 by pulling as indicated byarrow 572 in the same plane as the cartridge. It should be understoodthat in some embodiments, the finger 570 pushes instead of pulls torotate the cartridge in the correct direction. The finger 570 may alsobe adapted to engage ratchet surfaces 706 as seen in FIG. 66 to rotate acartridge. The finger 570 may also incorporate vertical motion tocoordinate with the rising and lowering of the cartridge 500. The motionof finger 570 may also be powered by electric actuators such as astepper motor or other device useful for achieving motion. FIG. 56B alsoshows a portion of the encoder 573 used in position sensing.

Referring now to FIG. 56C, a still further view of the slider 564 andarm 569 is shown. The arm 569 moves to engage portion 522 as indicatedby arrow 575 and this causes the cam 550 to rotate as indicated by arrow577. In this particular embodiment, the cam 550 rotates about ⅛ of anrotation with each pull of the slider 564. When the slider 564 is returnto its home or start position, the arm 569 rides over the portion 522.The movement of the slider also allows the cam surface 544 to rotateabout pivot point 579. A resilient member 580 may be coupled to the camsurface 544 to cause it to rotate counterclockwise when the arm 569moves in the direction of arrow 567. The pin 580 will remain in contactwith the arm 569. As the cam surface 544 rotates a first surface 582will contact the pin 583 on the gripper block 584 and pull the pin 583back to park a penetrating member into a coupling or narrowed portion542 of the cartridge 500 as seen in FIG. 55A. As the arm 569 is broughtback to the home position, the cam surface 544 rotates back and a secondsurface 586 that rotates clockwise and pushes the penetrating memberforward to be released from the narrowed portion 542 resulting in aposition as seen in FIG. 55B. It should be understood that in someembodiments, the release and/or parking of lancet from portion 542 maybe powered by the driver 588 without using the mechanical assistancefrom cam surface 544.

In another embodiment of the cartridge device, a mechanical feature maybe included on the cartridge so that there is only one way to load itinto the apparatus. For example, in one embodiment holding 50penetrating members, the cartridge may have 51 pockets or cavities. The51^(st) pocket will go into the firing position when the device isloaded, thus providing a location for the gripper to rest in thecartridge without releasing a penetrating member from a sterileenvironment. The gripper 530 in that zeroth position is inside thepocket or cavity and that is the reason why one of the pockets may beempty. Of course, some embodiments may have the gripper 530 positionedto grip a penetrating member as the cartridge 500 is loaded into thedevice, with the patient lancing themselves soon afterwards so that thepenetrating member is not contaminated due to prolonged exposure outsidethe sterile enclosure. That zeroth position may be the start and finishposition. The cartridge may also be notched to engaged a protrusion onthe apparatus, thus also providing a method for allowing the penetratingmember to loaded or unloaded only in one orientation. Essentially, thecartridge 500 may be keyed or slotted in association with the apparatusso that the cartridge 500 can only be inserted or removed at oneorientation. For example as seen in FIG. 56D, the cartridge 592 may havea keyed slot 593 that matches the outline of a protrusion 594 such thatthe cartridge 592 may only be removed upon alignment of the slot 593 andprotrusion 594 upon at the start or end positions. It should beunderstood that other keyed technology may be used and the slot or keymay be located on an outer periphery or other location on the cartridge592 in manner useful for allowing insertion or removal of the cartridgefrom only one or a select number of orientations.

Referring now to FIG. 57, a cross-section of another embodiment of acavity 600 housing a penetrating member is shown. The cavity 600 mayinclude a depression 602 for allowing the gripper 530 to penetratesufficiently deeply into the cavity to frictionally engage thepenetrating member 541. The penetrating member may also be housed in agroove 604 that holds the penetrating member in place prior to and afteractuation. The penetrating member 541 is lifted upward to clear thegroove 604 during actuation and exits through opening 506.

Referring now to FIG. 58, another variation on the system according tothe present invention will now be described. FIG. 58 shows a lancingsystem 610 wherein the penetrating members have their sharpened tippointed radially inward. The finger or other tissue of the patient isinserted through the center hole 611 to be pierced by the member 612.The penetrating member gripper 530 coupled to drive force generator 613operate in substantially the same manner as described in FIGS. 54A-G.The punch portions 521 and 522 operate in substantially the same mannerto release the penetrating members from the sterile enclosures. Thepunch portion 522 may be placed on the inner periphery of the device,where the penetrating member exit is now located, so that sterileenclosure material is cleared out of the path of the penetrating memberexit.

Referring now to FIG. 59, a still further variation on the lancingsystem according to the present invention will now be described. In theembodiments shown in FIGS. 53-54, the penetrating member gripper 530approaches the penetrating member from above and at least a portion ofthe drive system is located in a different plane from that of thecartridge 500. FIG. 59 shows an embodiment where the penetrating memberdriver 620 is in substantially the same plane as the penetrating member622. The coupler 624 engages a bent or L shaped portion 626 of themember 622. The cartridge 628 can rotate to engage a new penetratingmember with the coupler 624 without having to move the cartridge orcoupler vertically. The next penetrating member rotates into position inthe slot provided by the coupler 624. A narrowed portion of thecartridge acts as a penetrating member guide 630 near the distal end ofthe penetrating member to align the penetrating member as it exits thecartridge.

The coupler 624 may come in a variety of configurations. For example,FIG. 60A shows a coupler 632 which can engage a penetrating member 633that does not have a bent or L-shaped portion. A radial cartridgecarrying such a penetrating member 633 may rotate to slide penetratingmember into the groove 634 of the coupler 632. FIG. 60B is a front viewshowing that the coupler 632 may include a tapered portion 636 to guidethe penetrating member 633 into the slot 634. FIG. 60C shows anembodiment of the driver 620 using a coupler 637 having a slot 638 forreceiving a T-shaped penetrating member. The coupler 637 may furtherinclude a protrusion 639 that may be guided in an overhead slot tomaintain alignment of the drive shaft during actuation.

Referring now to FIG. 61, a cartridge 640 for use with an in-planedriver 620 is shown. The cartridge 640 includes an empty slot 642 thatallows the cartridge to be placed in position with the driver 620. Inthis embodiment, the empty slot 642 allows the coupler 644 to bepositioned to engage an unused penetrating member 645 that may berotated into position as shown by arrow 646. As seen in FIG. 61, thecartridge 640 may also be designed so that only the portion of thepenetrating member that needs to remain sterile (i.e. the portions thatmay actually be penetrating into tissue) are enclosed. As seen in FIG.61, a proximal portion 647 of the penetrating member is exposed. Thisexposed proximal portion may be about 70% of the penetrating member. Inother embodiments it may be between about 69% to about 5% of thepenetrating member. The cartridge 640 may further include, but notnecessarily, sealing protrusions 648. These protrusions 648 arereleasably coupled to the cartridge 640 and are removed from thecartridge 640 by remover 649 as the cartridge rotates to placepenetrating member 645 into the position of the active penetratingmember. The sterile environment is broken prior to actuation of themember 645 and the member does not penetrate sterile enclosure materialthat may dull the tip of the penetrating member during actuation. Afracturable seal material 650 may be applied to the member to sealagainst an inner peripheral portion of the cartridge.

Referring now to FIG. 62, a still further embodiment of a cartridge foruse with the present invention will be described. This cartridge 652includes a tapered portion 654 for allowing the coupler 655 to enter thecavity 656. A narrowed portion 657 guides the penetrating member 658.The coupler 655 may have, but does not necessarily have, movable jaws659 that engage to grip the penetrating member 658. Allowing the couplerto enter the cavity 656 allows the alignment of the penetrating memberto be better maintained during actuation. This tapered portion 654 maybe adapted for use with any embodiment of the cartridge disclosedherein.

Referring now to FIG. 63, a linear cartridge 660 for use with thepresent invention will be described. Although the present invention hasbeen shown in use with radial cartridges, the lancing system may beadapted for use with cartridges of other shapes. FIGS. 79-83 show othercartridges of varying shapes adaptable for use with the presentinvention. FIG. 63 illustrates a cartridge 660 with only a portion 662providing sterile protection for the penetrating members. The cartridge660, however, provides a base 664 on which a penetrating member 665 canrest. This provides a level of protection of the penetrating memberduring handling. The base 664 may also be shaped to provide slots 666 inwhich a penetrating member 667 may be held. The slot 666 may also beadapted to have a tapered portion 668. These configurations may beadapted for use with any of the embodiments disclosed herein, such asthe cartridge 652.

Referring now to FIGS. 64A-64C, a variety of different devices are shownfor releasing the sterility seal covering a lateral opening 503 on thecartridge 500. FIG. 64A shows a rotating punch device 670 that hasprotrusions 672 that punch out the sterility barrier creating openings674 from which a penetrating member can exit without touching thesterility barrier material. FIG. 64B shows a vertically rotating device676 with shaped protrusions 678 that punch down the sterility barrier679 as it is rotated to be in the active, firing position. FIG. 64Cshows a punch 680 which is positioned to punch out barrier 682 when thecartridge is lowered onto the punch. The cartridge is rotated and thepunch 680 rotates with the cartridge. After the cartridge is rotated tothe proper position and lifted up, the punch 680 is spring loaded orotherwise configured to return to the position to engage the sterilitybarrier covering the next unused penetrating member.

Referring now to FIG. 65A-65B, another type of punch mechanism for usewith a punch plate 520 will now be described. The device shown in FIGS.53-54 shows a mechanism that first punches and then rotates or indexesthe released penetrating member into position. In this presentembodiment, the cartridge is rotated first and then the gripper andpunch may move down simultaneously. FIG. 65A shows a punch 685 having afirst portion 686 and a second portion 687. As seen in cross-sectionalview of FIG. 65B, the penetrating member gripper 690 is located insidethe punch 685. Thus the penetrating of the sterility barrier isintegrated into the step of engaging the penetrating member with thegripper 690. The punch 685 may include a slot 692 allowing a portion 694of the gripper 690 to extend upward. A lateral opening 695 is providedfrom which a penetrating member may exit. In some embodiments, the punchportion 687 is not included with punch 686, instead relying on someother mechanism such as those shown in FIGS. 64A-64C to press down onbarrier material covering a lateral opening 503.

Referring now to FIG. 66, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 66 shows acartridge 700 with a plurality of cavities 702 and individualdeflectable portions or fingers 704. The ends of the protective cavities702 may be divided into individual fingers (such as one for each cavity)on the outer periphery of the disc. Each finger 704 may be individuallysealed with a foil cover (not shown for ease of illustration) tomaintain sterility until the time of use. Along the inner periphery ofthe cartridge 700 are raised step portions 706 to create a ratchet typemechanism. As seen in FIG. 67, a penetrating member 708 may be housed ineach cavity. The penetrating member may rest on a raised portion 710. Anarrowed portion 712 pinches the proximal portions of the penetrationmember 708. Each cavity may include a wall portion 714 into which thepenetrating member 708 may be driven after the penetrating member hasbeen used. FIG. 68 shows the penetrating member gripper 716 lowered toengage a penetrating member 708. For ease of illustration, a sterilitybarrier covering each of the cavities is not shown.

Referring now to FIGS. 69A-69L, the sequence of steps for actuating apenetrating member in a cartridge 700 will be described. It should beunderstood that in other embodiments, steps may be combined or reducedwithout departing from the spirit of the present invention. The lastpenetrating member to be used may be left in a retracted position,captured by a gripper 716. The end of the protective cavity 704 may bedeflected downward by the previous actuation. The user may operate amechanism such as but not limited to a thumbwheel, lever, crank, slider,etc. . . . that advances a new penetrating member 720 into launchposition as seen in FIG. 69A. The mechanism lifts a bar that allows theprotective cavity to return to its original position in the plane of thedisc.

In this embodiment as shown in FIG. 69B, the penetrating member guide722 presses through foil in rear of pocket to “home” penetrating memberand control vertical clearance. For ease of illustration, actuationdevices for moving the penetrating member guide 722 and other mechanismsare not shown. They may be springs, cams, or other devices that canlower and move the components shown in these figures. In someembodiments, the cartridge 700 may be raised or lowered to engage thepenetrating member guide 722 and other devices.

As seen in FIG. 69C, the plough or sterile enclosure release device 724is lowered to engage the cartridge 700. In some embodiments, the disc orcartridge 700 may raised part way upward until a plough or plow blade724 pierces the sterility barrier 726 which may be a foil covering.

Referring now to FIG. 69D, the plough 724 clears foil from front ofpocket and leaves it attached to cartridge 700. The plough 724 is drivenradially inward, cutting open the sterility barrier and rolling thescrap into a coil ahead of the plough. Foil naturally curls over andforms tight coil when plough lead angle is around 55 degs to horizontal.If angle of the plough may be between about 60-40 degs, preferablycloser to 55 degs. In some embodiments, the foil may be removed in sucha manner that the penetrating member does not need to pierce any sterileenclosure materials during launch.

Referring now to FIG. 69E, the gripper 716 may be lowered to engage thebare penetrating member or piercing member 720. Optionally, the disc orcartridge 8000 may be raised until the penetrating member 720 is pressedfirmly into the gripper 716. Although not shown in the present figure,the penetrating member driver or actuator of the present embodiment mayremain in the same horizontal plane as the penetrating member.

As seen in FIG. 69F, a bar 730 may be pressed downward on the outer end732 of the protective cavity to deflect it so it is clear of the path ofthe penetrating member. In the present embodiment, the bar 730 is shapedto allow the bare penetrating member 720 to pass through. It should beunderstood that other shapes and orientations of the bar (such ascontacting only one side or part of end 732) may be used to engage theend 732.

Referring now to FIG. 69G, an electrical solenoid or other electronic orfeed-back controllable drive may actuate the gripper 716 radiallyoutward, carrying the bare penetrating member 720 with it. The barepenetrating member projects from the protective case and into the skinof a finger or other tissue site that has been placed over the apertureof the actuator assembly. Suitable penetrating member drivers aredescribed in commonly assigned, copending U.S. patent application Ser.No. 10/127,395 filed Apr. 19, 2002.

Referring now to FIG. 69H, the solenoid or other suitable penetratingmember driver retracts the bare penetrating member 720 into a retractedposition where it parks until the beginning of the next lancing cycle.

Referring now to FIG. 69I, bar 730 may be released so that the end 150returns to an in-plane configuration with the cartridge 800.

As seen in FIG. 69J, the gripper 716 may drive a used bare penetratingmember radially outward until the sharpened tip is embedded into aplastic wall 714 at or near the outward end 732 of the cavity thusimmobilizing the contaminated penetrating member.

As seen in FIGS. 69K and 69L, the plough 724, the gripper 716, andpenetrating member guide 722 may all be disengaged from the barepenetrating member 720. Optionally, it should be understood that theadvance mechanism may lower the cartridge 700 from the gripper 716. Theused penetrating member, restrained by the tip embedded in plastic, andby the cover foil at the opposite end, is stripped from the gripper. Thedisc or cartridge 700 may be rotated until a new, sealed; sterilepenetrating member is in position under the launch mechanism.

Referring now to FIGS. 70 and 71, one object for some embodiments of theinvention is to include blood sampling and sensing on this penetratingmember actuation device. In the present embodiment, the drive mechanism(gripper 738 and solenoid drive coil 739) may be used to drive apenetrating member into the skin and couple this lancing event toacquire the blood sample as it forms at the surface of the finger. In afirst embodiment shown in FIG. 70, microfluidic module 740 bearing theanalyte detecting member chemistry and detection device 742 (FIG. 71) iscouple on to the shaft of the penetrating member 720. The drive cycledescribed above may also actuate the module 740 so that it rests at thesurface of the finger to acquire blood once the penetrating memberretracts from the wound. The module 740 is allowed to remain on thesurface of the finger or other tissue site until the gripper 738 hasreached the back end 744 of the microfluidics module 740, at which pointthe module is also retracted into the casing. The amount of time themodule 740 remains on the finger, in this embodiment, may be variedbased on the distance the end 744 is located and the amount of time ittakes the gripper to engage it on the withdrawal stroke. The bloodfilled module 740, filled while the module remains on pierced tissuesite, may then undergo analyte detection by means such as optical orelectrochemical sensing.

The blood may be filled in the lumen that the penetrating member was inor the module may have separately defined sample chambers to the side ofthe penetrating member lumen. The analyte detecting member may also beplaced right at the immediate vicinity or slightly setback from themodule opening receiving blood so that low blood volumes will stillreach the analyte detecting member. In some embodiments, the analytesensing device and a visual display or other interface may be on boardthe apparatus and thus provide a readout of analyte levels without needto plug apparatus or a test strip into a separate reader device. As seenin FIG. 71, the cover 746 may also be clear to allow for light to passthrough for optical sensing. The analyte detecting member may be usedwith low volumes such as less than about 1 microliter of sample,preferably less than about 0.6 microliter, more preferably less thanabout 0.3 microliter, and most preferably less than about 0.1 microliterof sample.

In another embodiment as seen in FIG. 72, sensing elements 760 may bedirectly printed or formed on the top of bottom of the penetratingmember cartridge 700, depending on orientation. The bare penetratingmember 720 is then actuated through a hole 762 in the plastic facing,withdrawn into the radial cavity followed by the blood sample.Electrochemical or optical detection for analyte sensing may then becarried out (FIG. 72). Again the cavity 766 may have a clear portion toallow light to pass for optical sensing. In one embodiment, amultiplicity of miniaturized analyte detecting member fields may beplaced on the floor of the radial cavity as shown in FIG. 72 or on themicrofluidic module shown in FIG. 71 to allow many tests on a singleanalyte form a single drop of blood to improve accuracy and precision ofmeasurement. Although not limited in this manner, additional analytedetecting member fields or regions may also be included for calibrationor other purposes.

Referring now to FIG. 73, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 73 shows oneembodiment of a cartridge 800 which may be removably inserted into anapparatus for driving penetrating members to pierce skin or tissue. Thecartridge 800 has a plurality of penetrating members 802 that may beindividually or otherwise selectively actuated so that the penetratingmembers 802 may extend outward from the cartridge, as indicated by arrow804, to penetrate tissue. In the present embodiment, the cartridge 800may be based on a flat disc with a number of penetrating members suchas, but in no way limited to, (25, 50, 75, 100, . . . ) arrangedradially on the disc or cartridge, 800. It should be understood thatalthough the cartridge 800 is shown as a disc or a disc-shaped housing,other shapes or configurations of the cartridge may also work withoutdeparting from the spirit of the present invention of placing aplurality of penetrating members to be engaged, singly or in somecombination, by a penetrating member driver.

Each penetrating member 802 may be contained in a cavity 806 in thecartridge 800 with the penetrating member's sharpened end facingradially outward and may be in the same plane as that of the cartridge.The cavity 806 may be molded, pressed, forged, or otherwise formed inthe cartridge. Although not limited in this manner, the ends of thecavities 806 may be divided into individual fingers (such as one foreach cavity) on the outer periphery of the disc. The particular shape ofeach cavity 806 may be designed to suit the size or shape of thepenetrating member therein or the amount of space desired for placementof the analyte detecting members 808. For example and not limitation,the cavity 806 may have a V-shaped cross-section, a U-shapedcross-section, C-shaped cross-section, a multi-level cross section orthe other cross-sections. The opening 810 through which a penetratingmember 802 may exit to penetrate tissue may also have a variety ofshapes, such as but not limited to, a circular opening, a square orrectangular opening, a U-shaped opening, a narrow opening that onlyallows the penetrating member to pass, an opening with more clearance onthe sides, a slit, a configuration as shown in FIG. 75, or the othershapes.

In this embodiment, after actuation, the penetrating member 802 isreturned into the cartridge and may be held within the cartridge 800 ina manner so that it is not able to be used again. By way of example andnot limitation, a used penetrating member may be returned into thecartridge and held by the launcher in position until the next lancingevent. At the time of the next lancing, the launcher may disengage theused penetrating member with the cartridge 800 turned or indexed to thenext clean penetrating member such that the cavity holding the usedpenetrating member is position so that it is not accessible to the user(i.e. turn away from a penetrating member exit opening). In someembodiments, the tip of a used penetrating member may be driven into aprotective stop that hold the penetrating member in place after use. Thecartridge 800 is replaceable with a new cartridge 800 once all thepenetrating members have been used or at such other time or condition asdeemed desirable by the user.

Referring still to the embodiment in FIG. 73, the cartridge 800 mayprovide sterile environments for penetrating members via seals, foils,covers, polymeric, or similar materials used to seal the cavities andprovide enclosed areas for the penetrating members to rest in. In thepresent embodiment, a foil or seal layer 820 is applied to one surfaceof the cartridge 800. The seal layer 820 may be made of a variety ofmaterials such as a metallic foil or other seal materials and may be ofa tensile strength and other quality that may provide a sealed, sterileenvironment until the seal layer 820 is penetrate by a suitable orpenetrating device providing a preselected or selected amount of forceto open the sealed, sterile environment. Each cavity 806 may beindividually sealed with a layer 820 in a manner such that the openingof one cavity does not interfere with the sterility in an adjacent orother cavity in the cartridge 800. As seen in the embodiment of FIG. 73,the seal layer 820 may be a planar material that is adhered to a topsurface of the cartridge 800.

Depending on the orientation of the cartridge 800 in the penetratingmember driver apparatus, the seal layer 820 may be on the top surface,side surface, bottom surface, or other positioned surface. For ease ofillustration and discussion of the embodiment of FIG. 73, the layer 820is placed on a top surface of the cartridge 800. The cavities 806holding the penetrating members 802 are sealed on by the foil layer 820and thus create the sterile environments for the penetrating members.The foil layer 820 may seal a plurality of cavities 806 or only a selectnumber of cavities as desired.

In a still further feature of FIG. 73, the cartridge 800 may optionallyinclude a plurality of analyte detecting members 808 on a substrate 822which may be attached to a bottom surface of the cartridge 800. Thesubstrate may be made of a material such as, but not limited to, apolymer, a foil, or other material suitable for attaching to a cartridgeand holding the analyte detecting members 808. As seen in FIG. 73, thesubstrate 822 may hold a plurality of analyte detecting members, such asbut not limited to, about 10-50, 50-100, or other combinations ofanalyte detecting members. This facilitates the assembly and integrationof analyte detecting members 808 with cartridge 800. These analytedetecting members 808 may enable an integrated body fluid samplingsystem where the penetrating members 802 create a wound tract in atarget tissue, which expresses body fluid that flows into the cartridgefor analyte detection by at least one of the analyte detecting members808. The substrate 822 may contain any number of analyte detectingmembers 808 suitable for detecting analytes in cartridge having aplurality of cavities 806. In one embodiment, many analyte detectingmembers 808 may be printed onto a single substrate 822 which is thenadhered to the cartridge to facilitate manufacturing and simplifyassembly. The analyte detecting members 808 may be electrochemical innature. The analyte detecting members 808 may further contain enzymes,dyes, or other detectors which react when exposed to the desiredanalyte. Additionally, the analyte detecting members 808 may comprise ofclear optical windows that allow light to pass into the body fluid foranalyte analysis. The number, location, and type of analyte detectingmember 808 may be varied as desired, based in part on the design of thecartridge, number of analytes to be measured, the need for analytedetecting member calibration, and the sensitivity of the analytedetecting members. If the cartridge 800 uses an analyte detecting memberarrangement where the analyte detecting members are on a substrateattached to the bottom of the cartridge, there may be through holes (asshown in FIG. 76), wicking elements, capillary tube or other devices onthe cartridge 800 to allow body fluid to flow from the cartridge to theanalyte detecting members 808 for analysis. In other configurations, theanalyte detecting members 808 may be printed, formed, or otherwiselocated directly in the cavities housing the penetrating members 802 orareas on the cartridge surface that receive blood after lancing.

The use of the seal layer 820 and substrate or analyte detecting memberlayer 822 may facilitate the manufacture of these cartridges 10. Forexample, a single seal layer 820 may be adhered, attached, or otherwisecoupled to the cartridge 800 as indicated by arrows 824 to seal many ofthe cavities 806 at one time. A sheet 822 of analyte detecting membersmay also be adhered, attached, or otherwise coupled to the cartridge 800as indicated by arrows 825 to provide many analyte detecting members onthe cartridge at one time. During manufacturing of one embodiment of thepresent invention, the cartridge 800 may be loaded with penetratingmembers 802, sealed with layer 820 and a temporary layer (not shown) onthe bottom where substrate 822 would later go, to provide a sealedenvironment for the penetrating members. This assembly with thetemporary bottom layer is then taken to be sterilized. Aftersterilization, the assembly is taken to a clean room (or it may alreadybe in a clear room or equivalent environment) where the temporary bottomlayer is removed and the substrate 822 with analyte detecting members iscoupled to the cartridge as shown in FIG. 73. This process allows forthe sterile assembly of the cartridge with the penetrating members 802using processes and/or temperatures that may degrade the accuracy orfunctionality of the analyte detecting members on substrate 822. As anonlimiting example, the entire cartridge 800 may then be placed in afurther sealed container such as a pouch, bag, plastic molded container,etc. . . . to facilitate contact, improve ruggedness, and/or allow foreasier handling.

In some embodiments, more than one seal layer 820 may be used to sealthe cavities 806. As examples of some embodiments, multiple layers maybe placed over each cavity 806, half or some selected portion of thecavities may be sealed with one layer with the other half or selectedportion of the cavities sealed with another sheet or layer, differentshaped cavities may use different seal layer, or the like. The seallayer 820 may have different physical properties, such as those coveringthe penetrating members 802 near the end of the cartridge may have adifferent color such as red to indicate to the user (if visuallyinspectable) that the user is down to say 10, 5, or other number ofpenetrating members before the cartridge should be changed out.

Referring now to FIGS. 74 and 75, one embodiment of the microfluidicsused with the analyte detecting members 808 in cartridge 800 will now bedescribed. For ease of illustration, the shape of cavity 806 has beensimplified into a simple wedge shape. It should be understood that moresophisticated configurations such as that shown in FIG. 73 may be used.FIG. 74 shows a channel 826 that assists in drawing body fluid towardsthe analyte detecting members 808. In the present embodiment, twoanalyte detecting members 808 are shown in the cavity 806. This ispurely for illustrative purposes as the cavity 806 may have one analytedetecting member or any other number of analyte detecting members asdesired. Body fluid entering cavity 806, while filling part of thecavity, will also be drawn by capillary action through the groove 826towards the analyte detecting members 808. The analyte detecting members808 may all perform the same analysis, they may each perform differenttypes of analysis, or there may be some combination of the two (somesensors perform same analysis while others perform other analysis).

FIG. 75 shows a perspective view of a cutout of the cavity 806. Thepenetrating member 802 (shown in phantom) is housed in the cavity 806and may extend outward through a penetrating member exit opening 830 asindicated by arrow 832. The position of the tip of penetrating member802 may vary, such as being near the penetrating member exit port orspaced apart from the exit. The location of the tip relative to theanalyte detecting member 808 may also be varied, such as being spacedapart or away from the analyte detecting member or collocated or in theimmediate vicinity of the analyte detecting member. Fluid may then enterthe cavity 806 and directed by channel 826. The channel 826 as shown inFIG. 75 is a groove that is open on top. The channel 826 may be entirelya groove with an open top or it may have a portion that is has a sealedtop forming a lumen, or still further, the groove may be closed exceptfor an opening near the penetrating member exit opening 830. It shouldbe understood that capillary action can be achieved using a groovehaving one surface uncovered. In some embodiments, the analyte detectingmember 808 is positioned close to the penetrating member exit opening830 so that the analyte detecting member 808 may not need a capillarygroove or channel to draw body fluid, such as in FIG. 78.

As seen in FIGS. 75 and 76, the cavity 806 may include the substrate 822coupled to its bottom surface containing the analyte detecting members808. With the analyte detecting members 808 located on the underside ofthe cartridge 800 as seen in the embodiment of FIG. 76, the cartridge800 may include at least one through hole 834 to provide a passage forbody fluid to pass from the cavity 806 to the analyte detecting member808. The size, location, shape, and other features of the through hole834 may be varied based on the cavity 806 and number of analytedetecting members 808 to be provided. In other embodiments, wickingelements or the like may be used to draw body fluid from the groove 826to down to the analyte detecting member 808 via the through hole orholes 834.

Referring now to FIG. 77, a variety of groove and analyte detectingmember configurations are shown on a single cartridge. Theseconfigurations are shown only for illustrative purposes and a singlecartridge may not incorporate each of these configurations. Someembodiments may use any of the detecting members, singly or incombination. It should be understood, however, that analyte detectingmember configuration could be customized for each cavity, such as butnot limited to, using a different number and location of analytedetecting members depending lancing variables associated with thatcavity, such as but not limited to, the time of day of the lancingevent, the type of analyte to be measured, the test site to be lanced,stratum corneum hydration, or other lancing parameter. As a nonlimitingexample, the detecting members may be moved closer towards the outeredge of the disc, more on the side walls, any combination, or the like.

FIG. 77 shows a penetrating member 802 in a cavity 838 with threeanalyte detecting members 808 in the cavity. For ease of illustration,the penetrating member 802 is omitted from the remaining cavities sothat the analyte detecting member configurations can be more easilyseen. Cavity 840 has a channel 826 with two analyte detecting members808. Cavity 842 has a channel 844 coupled to a single analyte detectingmember 808. Cavities 846 and 848 have one and two analyte detectingmembers 808, respectively. The analyte detecting members 808 in thosecavities may be located directly at the penetrating member exit from thecartridge or substantially at the penetrating member exit. Other analytedetecting member configurations are also possible, such as but notlimited to, placing one or more analyte detecting members on a side wallof the cavity, placing the analyte detecting members in particulararrays (for example, a linear array, triangular array, square array,etc. . . . ) on the side wall or bottom surface, using mixed types ofanalyte detecting members (for example, electrochemical and optical, orsome other combination), or mixed positioning of analyte detectingmembers (for example, at least one analyte detecting member on thesubstrate below the cartridge and at least one analyte detecting memberin the cavity).

FIG. 78 shows an embodiment of cartridge 800 where the analyte detectingmember 850 is located near the distal end of cavity 806. The analytedetecting member 850 may be formed, deposited, or otherwise attachedthere to the cartridge 800. In another embodiment, the analyte detectingmember 850 may be a well or indentation having a bottom with sufficienttransparency to allow an optical analyte detecting member to detectanalytes in fluid deposited in the well or indentation. The well orindentation may also include some analyte reagent that reacts(fluoresces, changes colors, or presents other detectable qualities)when body fluid is placed in the well. In a still further embodiment,analyte detecting member 850 may be replaced with a through hole thatallow fluid to pass there through. An analyte detecting member 808 on asubstrate 822 may be attached to the underside of the cartridge 800,accessing fluid passing from the cavity 806 down to the analytedetecting member 808.

As mentioned above, the analyte detecting members 808 may also be placedright at the immediate vicinity or slightly setback from the moduleopening receiving blood so that low blood volumes will still reach theanalyte detecting member. The analyte detecting members 808 may be usedwith low volumes such as less than about 1 microliter of sample,preferably less than about 0.6 microliter, more preferably less thanabout 0.3 microliter, and most preferably less than about 0.1 microliterof sample. Analyte detecting members 808 may also be directly printed orformed on the bottom of the penetrating member cartridge 800. In oneembodiment, a multiplicity of miniaturized analyte detecting memberfields may be placed on the floor of the radial cavity or on themicrofluidic module to allow many tests on a single analyte form asingle drop of blood to improve accuracy and precision of measurement.Although not limited in this manner, additional analyte detecting memberfields or regions may also be included for calibration or otherpurposes.

Referring now to FIGS. 79-84, further embodiments of the cartridge 800will now be described. FIG. 79 shows a cartridge 860 having ahalf-circular shape. FIG. 80 shows a cartridge 862 in the shape of apartial curve. FIG. 80 also shows that the cartridges 862 may be stackedin various configurations such as vertically, horizontally, or in otherorientations. FIG. 81 shows a cartridge 864 having a substantiallystraight, linear configuration. FIG. 82 shows a plurality of cartridges864 arranged to extend radially outward from a center 866. Eachcartridge may be on a slide (not shown for simplicity) that allows thecartridge 864 to slide radially outward to be aligned with a penetratingmember launcher. After use, the cartridge 864 is slide back towards thecenter 866 and the entire assembly is rotated as indicated by arrow 868to bring a new cartridge 864 into position for use with a penetratingmember driver. FIG. 83 shows a still further embodiment where aplurality of cartridges 800 may be stacked for use with a penetratingmember driver (see FIG. 85). The driver may be moved to align itselfwith each cartridge 800 or the cartridges may be moved to alightthemselves with the driver. FIG. 84 shows a still further embodimentwhere a plurality of cartridge 864 are coupled together with a flexiblesupport to define an array. A roller 870 may be used to move thecartridges 864 into position to be actuated by the penetrating memberdriver 872.

Referring now to FIG. 85, one embodiment of an apparatus 880 using aradial cartridge 800 with a penetrating member driver 882 is shown. Acontoured surface 884 is located near a penetrating member exit port886, allowing for a patient to place their finger in position forlancing. Although not shown, the apparatus 880 may include a humanreadable or other type of visual display to relay status to the user.The display may also show measured analyte levels or other measurementor feedback to the user without the need to plug apparatus 880 or aseparate test strip into a separate analyte reader device. The apparatus880 may include a processor or other logic for actuating the penetratingmember or for measuring the analyte levels. The cartridge 800 may beloaded into the apparatus 880 by opening a top housing of the apparatuswhich may be hinged or removably coupled to a bottom housing. Thecartridge 800 may also drawn into the apparatus 880 using a loadingmechanism similar in spirit to that found on a compact disc player orthe like. In such an embodiment, the apparatus may have a slot (similarto a CD player in an automobile) that allows for the insertion of thecartridge 800 into the apparatus 880 which is then automatically loadedinto position or otherwise seated in the apparatus for operationtherein. The loading mechanism may be mechanically powered orelectrically powered. In some embodiments, the loading mechanism may usea loading tray in addition to the slot. The slot may be placed higher onthe housing so that the cartridge 800 will have enough clearance to beloaded into the device and then dropped down over the penetrating memberdriver 882. The cartridge 800 may have an indicator mark or indexingdevice that allows the cartridge to be properly aligned by the loadingmechanism or an aligning mechanism once the cartridge 800 is placed intothe apparatus 880. The cartridge 800 may rest on a radial platform thatrotates about the penetrating member driver 882, thus providing a methodfor advancing the cartridge to bring unused penetrating members toengagement with the penetrating member driver. The cartridge 800 on itsunderside or other surface, may shaped or contoured such as withnotches, grooves, tractor holes, optical markers, or the like tofacilitate handling and/or indexing of the cartridge. These shapes orsurfaces may also be varied so as to indicate that the cartridge isalmost out of unused penetrating members, that there are only fivepenetrating members left, or some other cartridge status indicator asdesired.

A suitable method and apparatus for loading penetrating members has beendescribed previously in U.S. Ser. Nos. 60/393,706 filed Jul. 1, 2002 and60/393,707 filed Jul. 1, 2002, and are included here by reference forall purposes. Suitable devices for engaging the penetrating members andfor removing protective materials associated with the penetrating membercavity are described in U.S. Ser. Nos. 60/422,988 filed Nov. 1, 2002 and60/424,429 filed November 6, and are included here by reference for allpurposes. For example in the embodiment of FIG. 78, the foil or seallayer 820 may cover the cavity by extending across the cavity along atop surface 890 and down along the angled surface 892 to provide asealed, sterile environment for the penetrating member and analytedetecting members therein. A piercing element described in U.S. patentapplication 60/424,429 filed Nov. 6, 2002 has a piercing element andthen a shaped portion behind the element which pushes the foil to thesides of the cavity or other position so that the penetrating member 802may be actuated and body fluid may flow into the cavity.

Referring now to FIG. 86, a still further embodiment of a lancing systemaccording to the present invention will be described. A radial cartridge500 may be incorporated for use with a penetrating member driver 882. Apenetrating member may be driven outward as indicated by arrow 894. Aplurality of analyte detecting members are presented on a roll 895 thatis laid out near a penetrating member exit. The roll 895 may be advancedas indicated by arrow 896 so that used analyte detecting members aremoved away from the active site. The roll 895 may also be replaced by adisc holding a plurality of analyte detecting members, wherein theanalyte detecting member disc (not shown) is oriented in a planesubstantially orthogonal to the plane of cartridge 500. The analytedetecting member disc may also be at other angles not parallel to theplane of cartridge 500 so as to be able to rotate and present new,unused analyte detecting member in sequence with new unused penetratingmembers of cartridge 500.

Referring now to FIG. 87A, the cartridge 500 provides a high densitypackaging system for a lancing system. This form factor allows a patientto load a large number penetrating members through a single cartridgewhile maintaining a substantially handheld device. Of course such acartridge 500 may also be used in non-handheld devices. The presentcartridge 500 provide a high test density per volume of the disposable.For embodiments of a cartridge that includes analyte detecting membersin addition to penetrating members such as cartridge 800, the densitymay also be measured in terms of density of analyte detecting membersand penetrating members in a disposable. In other embodiments, thedensity may also be expressed in terms of analyte detecting members perdisposable. For example, by taking the physical volume of one embodimentor the total envelope, this number can be divided by the number ofpenetrating members or number of tests. This result is the volume perpenetrating member or per test in a cassetted fashion. For example, inone embodiment of the present invention, the total volume of thecartridge 500 is determined to be 4.53 cubic centimeters. In this oneembodiment, the cartridge 500 holds 50 penetrating members. Dividing thevolume by 50, the volume per test is arrived at 0.090 cubic centimeters.Conventional test devices such as drum is in the range of 0.720 or 0.670cubic centimeters and that is simply the volume to hold a plurality oftest strips. This does not include penetrating members as does thepresent embodiment 800. Thus, the present embodiment is at asubstantially higher density. Even a slightly lower density devicehaving penetrating members and analyte detecting members in the 0.500cubic centimeter range would be a vast improvement over known devicessince the numbers listed above for known devices does not includepenetrating members, only packaging per test strip.

Each penetrating member (or penetrating member and analyte detectingmember, as the case may be) may have a packing density, or occupiedvolume, in cartridge 500. In various embodiments, the packing density oroccupied volume of each penetrating member in cartridge 500 may be nomore than about 0.66 cm3, 0.05 cm3, 0.4 cm3, 0.3 cm3, 0.2 cm3, 0.1 cm3,0.075 cm3, 0.05 cm3, 0.025 cm3, 0.01 cm3, 0.090 cm3, 0.080 cm3, and thelike. These numbers applicable to volumes for penetrating members alone,or for combined penetrating members and analyte detecting members. Inother words, the volume required for each penetrating member does notexceed 0.66 cm3/penetrating member, 0.05 cm3/penetrating member, 0.4cm3/penetrating member, 0.3 cm3/penetrating member, 0.2 cm3/penetratingmember, 0.1 cm3/penetrating member, 0.075 cm3/penetrating member, 0.05cm3/penetrating member, 0.025 cm3/penetrating member, 0.01cm3/penetrating member, 0.090 cm3/penetrating member and the like. So,if the total package volume of the cartridge is defined as X and thecartridge includes Y number of penetrating members, penetrating membersand test area, or other unit 395, the volume for each unit does notexceed 0.66 cm3, 0.05 cm3, 0.4 cm3, 0.3 cm3, 0.2 cm3, 0.1 cm3, 0.075cm3, 0.05 cm3, 0.025 cm3, 0.01 cm3, 0.090 cm3, 0.080 cm3, and the like.

Referring now to FIG. 87B, a still further embodiment of a cartridgeaccording to the present invention will now be described. FIG. 87B showsa cross-section of a conical shaped cartridge with the penetratingmember being oriented in one embodiment to move radially outward asindicated by arrow 897. In another embodiment, the penetrating membermay be oriented to move radially inward as indicated by arrow 895. Thegripper may be positioned to engage the penetrating member from an innersurface or an outer surface of the cartridge.

Referring now to FIG. 88, nanowires may also be used to create lowvolume analyte detecting members used with the cartridge 800. Furtherdetails of a nanowire device is described in U.S. Provisional PatentApplication Ser. No. 60/433,286 filed Dec. 13, 2002, fully incorporatedherein by reference for all purposes. These nanowire analyte detectingmembers 898 may be incorporated into the cavity 806 housing thepenetrating member 802. They may be placed on the floor or bottomsurface of the cavity 806, on the wall, on the top surface, or anycombinations of some or all of these possibilities. The analytedetecting members 898 may be designed to have different sensitivityranges so as to enhance the overall sensitivity of an array of suchanalyte detecting members. Methods to achieve this may include, but arenot limited to, using nanowires of varying sizes, varying the number ofnanowires, or varying the amount of glucose oxidase or other glucosedetection material on the nanowires. These nanowire analyte detectingmembers may be designed to use low volumes of body fluid for eachsample, due to their size. In some embodiments, each of the analytedetecting members are accurate using volumes of body fluid sample lessthan about 500 nanoliters. In some embodiments, each of the analytedetecting members are accurate using volumes of body fluid sample lessthan about 300 nanoliters. In still other embodiments, each analytedetecting member is accurate with less than about 50 nanoliters, lessthan about 30 nanoliters, less than about 10 nanoliters, less than about5 nanoliters, and less than about 1 nanoliters of body fluid sample. Insome embodiments, the combined array of analyte detecting members usesless than 300 nanoliters of body fluid to arrive at an analytemeasurement.

Referring now to FIG. 89, a still further embodiment of the presentinvention will be described. FIG. 89 shows one embodiment of an opticalillumination system 910 for use with optical analyte detecting members(FIG. 91) that may be in contact with a body fluid sample. The overallsystem may include a plurality of analyte detecting members whichprovide some optical indicator, a light source 912 for providing lightto shine on the analyte detecting members, at least one light detector914, and a processor (not shown). The analyte detecting member oranalyte detecting members are exposed to a sample of the fluid ofunknown composition. A plurality of analyte detecting members may bearranged into an array of analyte detecting members exposed to one fluidsample, each group targeting a specific analyte and may contain ananalyte-specific chemical that interacts more specifically with oneanalyte than with some other analytes to be analyzed. Each analytedetecting member may also have different sensitivity ranges so as tomaximize overall sensitivity of an array of such analyte detectingmembers. The light source 912 shines light on at least one analytedetecting member to cause light interaction. The differences in theanalyte detecting members may lead to differences in the lightinteraction. The light detector detects the light interaction by theanalyte detecting members. The processor analyzes the light interactionby the analyte detecting members to take into account interference inlight interaction among the analytes, thereby determining theconcentration of the desired analyte in the fluid.

Referring still to the embodiment of FIG. 89, the light source 912 maybe but is not limited to an LED. An alternative LED 915 may also be usedwith the present invention. Light, illumination, or excitation energyfrom LED 912 travels along a path through a pinhole 916, a filter 917,and a lens 918. The light then comes into contact with a beamsplitter919 such as a dichroic mirror or other device useful for beamsplitting.The light is then directed towards lens 920 as indicated by arrow 921.The lens 920 focuses light onto the analyte detecting member (FIG. 91).This excitation energy may cause a detectable optical indicator from theanalyte detecting member. By way of example and not limitation,fluorescence energy may be reflected bay up the lens 920. This energypasses through the beamsplitter 919 and to lens 922 which is thenreceived by detector 914 as indicated by arrow 923. The detector 914measures the energy and this information is passed on to the processor(not shown) to determine analyte levels. The illumination system 910 mayalso include cells 924 on the disc surface. In this specific embodiment,a penetrating member 925 drive by a force generator 926 such as but notlimited to a solenoid may be used to obtain the fluid sample. A detent927 may also be included with the device along with other bare lancetsor penetrating members 928.

Referring now to FIG. 90, another embodiment of the illumination system910 is shown for use with a cartridge 929. Cartridge 929 is similar tocartridge 800. Cartridge 929 is a single cartridge having a plurality ofpenetrating members and a plurality of optical analyte detecting members(not shown). The cartridge 929 further includes a plurality of opticallytransparent portions 930 which may be but is not limited to windows orthe like for the light from LED 912 to shine into a cavity of thecartridge 929. In one embodiment, each cavity of the cartridge 929 mayinclude at least one transparent portion 930. This allows the light togenerate energy that may be read by analyte detecting member 914. Thecartridge 929 may be used a driver 882 to actuate penetrating membersand the cartridge 929 may rotate as indicated by arrow 931.

Referring now to FIG. 91, a cross-section of a similar embodiment of theillumination system is shown. This system 932 has source 912 with a lens933 having an excitation filter 934. This excitation filter 934, in oneembodiment, only allows excitation energy to pass. This filter 934allows the excitation energy to pass to dichroic mirror 935, but doesnot let it return to source 912. Excitation energy is reflected down asindicated by arrow 936. Lens 937 focuses the energy to optical analytedetecting member 938. Fluorescence energy 939 passes through thedichroic mirror 935 and towards a fluorescent filter 940. In oneembodiment, the fluorescent filter 940 only allows fluorescent energy topass through to lens 941. Thus, the detector 914 only receivesfluorescent energy from the analyte detecting member 938. It should beunderstood of course, that the filter may be changed to allow the typeof energy being generated by analyte detecting member 938 to pass. Insome embodiments, no filter may be used. The dichroic mirror 935 may bea Bk7 substrate, 63×40×8 mm. The filters may also be a Bk7 substrateabout 40 mm in diameter and about 6 mm thick. The lens 933, 937, and 941may be achormat:bfl=53.6, working aperture 38 mm.

Referring now to FIG. 92, a still further embodiment of an illuminationsystem 942 will be described. This system does not use a beamsplitter ordichroic mirror. Instead, both the source or LED 912 and detector 914have direct line of sight to the optical analyte detecting member 938.In this embodiment, multiple elements are combined into a singlehousing. For example, lens 943, lens 944, and filter 945 are combinedwhile lens 946, lens 947, and filter 948 are also combined.

Referring now to FIG. 93, a cross-section of a system similar to that ofFIG. 89 is shown in a housing 950. LED 912 sends light to mirror 919 toa light path 951 to cells 924 on a surface of the disc. A finger access952 allows a sample to be obtained and flow along a fluid pathway 953 tobe analyzed. A processor 954 may be coupled to detector 914 to analyzethe results.

Referring now to FIG. 94, a cross-section of a system similar to that ofFIG. 90 will be further described. This shows a cartridge 929 used witha driver 882. This allows for a radial design where the penetratingmembers extend radially outward as indicated by arrow 955. The driver882 may have a coupler portion that reciprocates as indicated by arrow956. FIGS. 95 and 96 provide further views of a system similar to thatof FIG. 89. The embodiment of FIGS. 95 and 96 may include additionallenses or filters as may be useful to refine energy detection.

Referring now to FIG. 97, the area of interest is the velocity profile1000 while the lancet is cutting through the skin layers in the fingeruntil it reaches a predetermined depth. More specifically, variation oflancet velocity through different phases of the inbound trajectory isshown in FIG. 97. In this embodiment, Phase I corresponds to the stratumcorneum, phase II to the epidermis and phase III to the dermis. At eachphase (and during the phase), the options are to maintain currentvelocity, increase current velocity or decrease current velocity. Basedon the thickness of the stratum corneum, velocity could be monitored andchanged in this embodiment at 9 points in the stratum corneum, 6 pointsin the epidermis, and 29 points in the dermis using the four edgedetection algorithm and the 360 strips per inch encoder strip. It shouldbe noted that although the embodiment of the driver discussed hereinproduces the previously discussed number of monitoring points for agiven displacement, other driver and position sensor embodiments may beused that would give higher or lower resolution.

For the purposes of the present discussion for this nonlimiting example,the skin is viewed as having three distinct regions or tissue layers:the stratum corneum SC (Phase I), the epidermis E (Phase II) and thedermis D (Phase III). In one embodiment, the lancet or penetratingmember 10 is accelerated to a first desired velocity. This velocity maybe predetermined or it may be calculated by the processor duringactuation. The processor is also used to control the lancet velocity intissue. At this velocity, the lancet 10 will impact the skin andinitiate cutting through the stratum corneum. The stratum corneum ishard, hence in this embodiment, maximum velocity of the penetratingmember 10 may be employed to efficiently cut through this layer, andthis velocity may be maintained constant until the lancet passes throughthe layer. Power will likely need to be applied to the lancet drive 12while the lancet is cutting through the stratum corneum in order tomaintain the first velocity. Average stratum corneum thickness is about225 μm. Using a four-edge detection algorithm for the position sensor 14of this embodiment, the opportunity to verify and feed back velocityinformation can be carried out at 225/17 or roughly 13 points. Inanother embodiment accelerating through the stratum corneum followingimpact may improve cutting efficiency. Acceleration may be possible ifthe lancet has not reached its target or desired velocity before impact.FIG. 4 shows the result of increasing ((a) arrows, maintaining ((b)arrows) or reducing ((c) arrows) velocity on the lancet trajectory foreach of the tissue layers.

On reaching the epidermis E (Phase II), an embodiment of a method maydecrease the velocity ((c) arrows) from the first velocity so thattissue compression is reduced in this second tissue layer. Thus thelancet 10, in this nonlimiting example, may have a second desiredvelocity that is less than the first velocity. The reduced speed in thesecond tissue layer may reduce the pain experienced by the mechanoreceptor nerve cells in the dermal layer (third tissue layer). In theabsence of tissue compression effects on the dermal layer, however,lancet velocity may be kept constant for efficient cutting (i.e. secondvelocity may be maintained the same as the first velocity). In anotherembodiment, velocity may be increased in the second tissue layer fromthe first velocity.

In Phase III, the lancet or penetrating member 10 may reach the bloodvessels and cut them to yield blood. The innervation of this thirdtissue layer and hence pain perception during lancing could be easilyaffected by the velocity profile chosen. In one embodiment, a thirddesired velocity may be chosen. The velocity may be chosen to minimizenerve stimulation while maintaining cutting efficiency. One embodimentwould involve reducing velocity from the second velocity to minimizepain, and may increase it just before the blood vessels to be cut. Thenumber of velocity measurement steps possible for the position sensordescribed above in the dermis is approximately 58. The user woulddetermine the best velocity/cutting profile by usage. The profile withthe least amount of pain on lancing, yielding a successful blood samplewould be programmable into the device.

Currently users optimize depth settings on mechanical launchers bytesting various settings and through usage, settle on a desired settingbased on lancing comfort. Embodiments of the device and methodsdiscussed herein provide a variety of velocity profiles (FIG. 97), whichcan be optimized by the user for controlled lancing, and may include:controlling the cutting speed of a lancet with the lancet within theskin; adjusting the velocity profile of the lancet while the lancet isin the skin based upon the composition of the skin layers; lancingaccording to precise regional velocity profiles based on variation incell type from the surface of the skin down through the epidermis anddermis; lancing at a desired velocity through any tissue layer andvarying the velocity for each layer. This may include maximum velocitythrough the stratum corneum, mediation of velocity through epidermis tominimize shock waves to pain sensors in dermis, and mediation ofvelocity through dermis for efficient cutting of blood vessels withoutstimulating pain receptors. Additional details may be found in commonlyassigned, co-pending U.S. patent application Ser. No. 10/420,535 filedApr. 21, 2003, included herein by reference.

Referring now to FIG. 98, a still further embodiment of an actuatoraccording to the present invention will now be described. The presentinvention relates to an actuator 1010 that will launch a lancet orpenetrating member 1020 into skin or an anatomical feature in acontrolled manner so as to produce a small drop of blood or body fluidwhile minimizing patient discomfort. As a nonlimiting example, energystored in a compressed spring, gas, or other actuation technique isreleased to actuate a lancet 1020. Through the use of processor 1012,the motion of the lancet or penetrating member 1020 is controlled by aniron-loaded fluid 1022 that changes viscosity in response to an imposedmagnetic field. A motor or other device (not shown) may be used tocontrol the retraction rate of the lancet 1020 from the skin or othertargeted anatomical feature. It should be understood, of course, thatother magnetically controllable fluid as known to those skilled in theart may also be used.

FIG. 98 documents the concept of using a magnetic fluid to control theaction of a mechanical spring. In the embodiment of FIG. 98, energy isstored in the compressed spring and released at the time of actuation.As previously discussed, other actuators besides the compressed springmay also be used without departing from the spirit of the presentinvention. The motion of the lancet is controlled by means of anelectromagnet that is arranged to produce a magnetic field in a fluidconsisting of fine iron particles suspended in oil, silicone fluid, orother medium. When a magnetic field is imposed on the fluid, the ironparticles align with the field, and resist motion. Fluid firmnessincreases with field strength. A suitable fluid can be purchased asMRF-132AD Rheonetic Fluid from Lord Corporation (888) 811-5673.

FIG. 99 provide details about launching and resetting the actuator forthe present embodiment. A firing catch 1030 is shown to hold the spring1010 in a cocked position prior to firing. An optically reflectivemember such as a flag 1032 is shown attached to the lancet coupler 1034to provide position feedback through an optical position transducer. Insome embodiments, the flag 1032 may be attached to a drive shaft (notshown). This feedback allows a processor 1012 to modulate the current tothe electromagnetic coil or other magnetic field generator as known toone skilled in the art, to control the actuation profile of the lancet.A disc 1036 is shown attached to the penetrating member coupler 1034 andthe disc is submerged in the rheonetic fluid. Suitable seals may be usedto contain the fluid while allowing the shaft 1038 to pass through thedashpot chamber. In some embodiments, the disc 1036 is mounted aboutshaft 1040 and the entire dashpot chamber is also mounted about aportion of the shaft 1040. A motor 1042, or other retraction device isshown to move the dashpot and carry the drive shaft back to the cockedposition. The motor then resets the dashpot to the desired stopposition, and the actuation cycle is ready to repeat.

One advantage of this design is that each actuator can be matched to aportion of the actuation cycle. Rapid energy release is provided by thespring 1010 to bring the lancet or penetrating member 1020 up to speed.In one embodiment, excess energy stored in the spring allows theactuator 1010 to maintain the desired lancet speed regardless of skin ortissue consistency. The rheonetic fluid 1022 in the dashpot, controlledby the electromagnet, dissipates the excess energy from the spring 1010.A DC reset motor 1042 can be driven at variable speeds by controllingthe motor drive current. By this means, the retraction speed of thelancet can be controlled.

Another advantage of this present embodiment is that power consumptionis reduced through the use of a small DC motor instead of a solenoid.The motor draws energy from a battery at a much lower rate and over alonger time, resulting in more efficient battery use.

In another aspect, the present embodiment provides a device for storingand rapidly releasing energy. The device controls the release of storedenergy to control motion, controls the release of energy to provide alow impact stop, controls the storage of energy to control retractionmotion, and stores energy for rapid release at the start of the nextcycle.

FIG. 100 shows that embodiments of the lancet actuators of FIGS. 98 and99 may be configured for use with a radial cartridge 1050 having aplurality of penetrating members 1020. Accordingly, these launchers maybe coupled with single use or multiple use lancing devices. As anonlimiting example, these devices may be used with a cartridge 500.

FIG. 101 shows a more detailed view of one embodiment of anelectromagnetic field generator 1052 coupled to a power source 1054controlled by a processor 1012.

FIG. 102 shows a still further embodiment similar to that shown in FIG.99. This embodiment includes an actuator 1010 (shown in this nonlimitingexample to be a spring), a disc 1036 coaxially mounted about a shaft1040 in a ferrofluid 1022, and a flag 1032 for monitoring lancet orpenetrating member position. The launch device of FIG. 102 may also beadapted for use with a radial cartridge (shown in phantom) having aplurality of penetrating members 1020 which may be coupled to thecoupler 1034.

Referring still to FIG. 102, energy is stored in the compressed springused as actuator 1010 and is released at the time of actuation. In thisembodiment, the motion of the penetrating member 1020 is controlled byan electromagnet 1052 that is arranged to produce a magnetic field in afluid consisting of fine iron particles or other material suspended inbut not limited to oil, silicone fluid, or other medium. When a magneticfield is imposed on the fluid, the iron particles align with the field,and resist motion. Fluid firmness increases with field strength. Suchfluid can be purchased as MRF-132AD Rheonetic Fluid from LordCorporation (888) 811-5673. A flag is shown attached to the drive shaftto provide position feedback through an optical position transducer.This feedback allows a processor to modulate the current to theelectromagnetic coil to control the actuation profile of the lancet. Adisc is shown attached to the drive shaft and submerged in the rheoneticfluid. Suitable seals are required to contain the fluid while allowingthe shaft to pass through the dashpot chamber. A motor, or other drivingdevice is shown to move the dashpot and carry the drive shaft back tothe cocked position. The motor then resets the dashpot to the desiredstop position, and the actuation cycle is ready to repeat. The advantageof this design is that each actuator may be matched to a portion of theactuation cycle. Rapid energy release is provided by the spring to bringthe lancet up to speed. Excess energy stored in the spring allows theactuator to maintain the desired lancet speed regardless of skinconsistency. The rheonetic fluid in the dashpot, controlled by theelectromagnet, dissipates the excess energy from the spring. Of course,other dashpots or dampers as disclosed herein or as known to one ofskill in the art may also be used. In one embodiment, a DC reset motorcan be driven at variable speeds by controlling the motor drive current.By this motor, the retraction speed of the penetrating member 1020 canbe controlled. A second advantage of this invention is that powerconsumption is reduced through the use of a small DC motor instead of asolenoid. The motor draws energy from a battery at a much lower rate andover a longer time, resulting in more efficient battery use. This hybriddevice could also be configured to yield a “smart braking” pattern sothat residual pain is minimized.

Referring now to FIGS. 103A to 103E, a still further embodiment of alancing apparatus relates to the spring actuation of a lancet to piercethe skin of a finger to produce a drop of blood for analysis. Bloodyield may be increased by causing the lancet to dwell at the end of itsstroke, and then retract at a slower rate.

As seen in FIG. 103A, one embodiment of a simple lancet launcher 1060comprises a compressed spring 1062 driving a moving mass 1064 that isattached to a lancet or penetrating member 1020 that pierces the skin ora targeted anatomical feature. When released (as seen in FIG. 103B), thespring 1062 accelerates the mass 1064 to a maximum speed at, or near,the point of contact between the lancet and skin. As the penetratingmember 1020 pierces the skin or anatomical feature, the drive spring1062 is extended and begins to slow the penetrating member 1020 (FIG.103C). The lancet penetration depth is set approximately by providing anadjustable mechanical stop 1066 for the moving mass. As soon as the massand lancet are stopped (FIG. 103D), the actuation spring 1062, which isextended by the momentum of the mass, begins to withdraw the lancet.

In some embodiments, electronic actuation methods can delay the start ofthe retraction, providing a dwell of the penetrating member 1020 in theskin or tissue to allow some visco-elastic setting of the skin andpromoting blood yield. Electronic actuators can also withdraw the lancetslowly to allow the blood to fill the wound channel, also promotingblood yield.

One economical solution to the lancet dwell requirement is to detach thedrive spring 1062 from the actuator housing, preventing extension of thespring. As illustrated in FIG. 103A, the drive spring 1062 acceleratesthe mass 1064 and lancet 1020 to speed, then travels with the mass asthe lancet enters the skin. At impact of the mass 1064 with the travelstop 1066, the spring 1062 continues to move until it is brought to astop in a partially compressed state (FIG. 103D). The drive spring 1062then rebounds and carries the mass 1064 and lancet 1020 with it (FIG.103E). By adjusting the weight and spring constant of the drive spring,the length of dwell produced by the drive spring rebound can be varied.Some control over the retraction speed can be had through adjusting theweight and damping of the drive spring.

In a still further embodiment, adding a second, lower spring-constant,return spring 1070 can provide further control over the retractionspeed. This return spring or return springs 1070 also insures that thepenetrating member 1020 retracts into the actuator housing instead ofrelying on the kinetic energy of the rebounding drive spring 1070. Asseen in FIGS. 104A-104C, a variety of return devices may be used. InFIG. 104A, the rebounding drive spring 1070 comprises an elastomericelement. In FIG. 104B, two rebounding springs 1072 and 1074 are used. Asseen in FIG. 104C, a single spring 1076 may be coaxially mounted aboutthe penetrating member 1020. In one regard, the embodiments shown inFIGS. 103-104 allow some control over the dwell and retraction speed ofthe lancet without resorting to expensive electronics. As a nonlimitingexample, these embodiments of FIGS. 103-104 may provide a dwell time fora lancet while piercing skin, a slower retraction rate during lancetwithdrawal, and positive retraction of the lancet. The mechanism may bepurely mechanical and less costly that electronic solutions.

Referring now to FIG. 105, a still further embodiment of an actuatoraccording to the present invention will now be described. The embodimentin FIG. 105 includes an inbound drive device 1080 and an outboundretraction device 1082. As seen in the FIG. 105, the inbound drivedevice 1080 is in its forward position. The inbound drive device 1080includes a plunger 1084 mounted with a spring 1086. Pulling back on theplunger 1084 pulls back on the gripper block 1088 and compresses thespring 1086. In this embodiment, a piston 1090 that slides into thedamper 1092 also moves with the plunger 1084. As the plunger 1084 ispulled back, it will come to a position (not shown) where the latch 1094engages the gripper block 1088 and holds the plunger 1084 in a launchposition. A button or other linking device may be coupled to the latch1094 to allow a user to launch the penetrating member 1020.

Moving the latch 1094 will release the gripper block 1088, release theenergy in the compressed spring 1086, and drive the penetrating member1020 towards the tissue or anatomical feature. It should be noted thatin this embodiment, the open end 1096 of the damper 1092 is cone orfunnel shaped. So initially, as the piston 1090 flies into the damper1092, it is flying there through air. As the piston 1090 is advanced, itruns into a narrowed portion of the damper 1092 that provides a closefit with the piston 1090. In some embodiments, there may be aninterference fit between the piston 1090 and the narrowed portion of thedamper 1092. In other embodiments, elastomeric material, other dampingmaterial, damping structure, or any combination of any of these elementsmay be used to provide a desired deceleration velocity profile. In thisnonlimiting example, the damper 1092 provides variable damping as itallows the gripper block 1088 to be accelerated to its terminalvelocity, driving the penetrating member 1020 at this high velocity,before encountering the damper 1092. As the piston travels further intothe damper, the damping factor may increase and provide furtherdeceleration to the gripper block 1088, thus also decelerating thepenetrating member 1020. In one embodiment, the gripper block 1088 slowsto near a complete stop prior to encountering the hard stop 1098 on thecarrier 1100. In some embodiments, the hard stop 1098 may be coveredwith an elastomeric material, other damping material, damping structure,or any combination of any of these elements to provide a controlled stopof the gripper block.

Referring still to the embodiment of FIG. 105, the outbound retractiondevice 1082 may use a motor 1102, or motor/gear box combination, to turna screw 1104 and retract carrier 1100 housing the inbound drive device1080. A switch 1106 positioned at the stop or some other sensor devicemay be used to indicate when the inbound stroke is completed. In otherembodiments, the motor 1102 or motor/gear box combination may beactivated prior to the gripper block 1088 impacting the stop or prior tothe gripper block 1088 coming to a complete stop. In such an embodiment,a sensor (not shown) may be positioned at a location prior to thegripper block 1088 reaching the stop 1098 and activate the motor 1102.This may provide a further method for decelerating or braking thegripper block 1088. In some embodiments, retraction by the outbounddevice 1082 may be delayed for a selectable amount of time such as, butnot limited to, 1-200 ms to allow the penetrating member to come to restin the tissue. In some further embodiments, retraction by the outbounddevice 1082 may be initiated for a selectable distance such as, but notlimited to, about 20-50 microns based on how far the screw 1104 pullsback on carrier 1126, and then stopped. It should be understood ofcourse, that other distances such as about 50-75 microns, 75-100microns, 100-125 microns may also be selected. This may be also used tominimize oscillation of the penetrating member 1020 against the tissueby withdrawing the penetrating member a small amount while thepenetrating member 1020 is coming to rest against the stop 1096. Afterthe penetrating member 1020 has come to a stop, it may be held for aselectable amount of time, such as but not limited to 1-200 ms and thenwithdrawn, or in some embodiments, it may be withdrawn without a delayperiod. All of the above elements may be coupled to a chassis 1108.

The depth of penetration by the penetrating member 1020 may also bedetermined by using the screw 1104 to control the position of thecarrier 1126. This controls depth since the protrusion distance by thepenetrating member 1020 from the carrier 1126 is substantially constant.Thus by varying the position of the carrier 1126 in this embodiment, thepenetration depth of the member 1020 relative to the front end 1127 isselectable. The position of the carrier 1126 may be selectable beforeeach lancing event. The position of carrier 1126 may be determined bythe user. The position of carrier 1126 may also be determined by aprocessor (not shown) which may track the penetration depth of previouslancing events and match it with some other variable such as but notlimited to pain feedback number from the user, spontaneous bloodgeneration, user hydration, or any other variable as described in U.S.patent application Ser. No. 10/335,215 filed Dec. 31, 2002. The screw1104 may be controlled to provide varied depth control with resolutionsuch as, but not limited to, about 1-5 microns, about 5-20 microns,other distance per adjustment. In some embodiments, this motor may be astepper motor. In other embodiments, it may be an actuator such as butnot limited to a pneumatic actuator, electric motor, or device with aposition sensor to provide feedback as to carrier position.

Referring now to FIGS. 106 to 109 show a still further embodiment of adevice having an inbound drive device 1110 and an outbound retractiondevice 1112. Referring now the configuration shown in FIG. 106, theinbound drive device 1110 may include a spring 1086 coupled to a gripperblock 1088. A plunger 1114 is provided for use with a damper 1116mounted concentrically about the shaft of the plunger. A latch 1094 witha flag portion 1118 is used to hold the gripper block 1088 in a launchposition with the spring 1086 compressed. As seen in FIG. 106, thepenetrating member 1020 may be guided by a front bearing 1120 and a rearbearing 1122. It should be understood, that some embodiments may use onebearing, while other embodiments, may use two or more bearings. The typeof clearance and support provided by the bearing may also be selectable.As a nonlimiting example, the bearings 1120 and 1122 may be structureswith openings therethrough and have side-to-side clearance from about20-40 microns and a vertical clearance from about 40-60 microns. Otherembodiments may have greater clearances such as, but not limited to,about 60-100 microns, about 100-300 microns, or the like.

Referring now to FIG. 107, the device is now shown in a firedconfiguration with the penetrating member 1020 positioned fully forward.As seen, the gripper block 1088 or penetrating member coupler is nowresting against the stop 1126. Prior to the gripper block 1088 coming toa rest, the damper 1116 (shown more clearly in FIG. 110) will engage theplunger 1114 to slow the gripper block 1088 prior to the block coming torest.

Referring now to FIG. 108, the device is now shown with the plunger 1116and gripper block 1088 in a fired configuration. However, the entirecarrier 1130 having the gripper block 1088 and plunger 1116 is retractedin the direction indicated by arrow 1132. As the carrier 1130 is drawninto the position shown in FIG. 108, the reset latch 1134 coupled to thechassis 1136 will lock into position against the gripper block 1088.With the reset latch 1134 in this position, the spring 1086 can becompressed and the gripper block 1088 moved back into its launchposition by moving the carrier 1126 forward as shown in FIG. 109.

Referring now to FIG. 109, carrier 1130 is advanced as indicated byarrow 1140. As the carrier 1130 is advanced by the screw 1104, the latch1094 will ride over the gripper block 1088 and then drop into place asshown in FIG. 109. The position in FIG. 109 shows the latch 1094 lockedagainst the gripper block 1088. A flag 1142 or cam surface offset to theside of the latch 1094 will engage a flag 1144 or cam surface on thereset latch 1134. This moves the reset latch 1134 downward, releasingthe latch from its locked position against the gripper block 1088.Eventually, the reset latch 1134 will ride underneath the gripper block1088 until the reset latch 1134 comes to rest in a position as shown inFIG. 106. In other embodiments, the reset latch 1124 may be coupled to adisposable such as a cartridge containing a plurality of penetratingmembers. In other embodiments, the reset latch 1134 may be attached tothe same frame of reference as that of the motor 1102. It may be part ofthe launcher and not the disposable. As a nonlimiting example, acantilever beam may run from the chassis portion under the motor 1102 tohold the reset latch 1134 in position, as part of the launcher and notthe disposable.

FIG. 110 shows an enlarged view of one embodiment of the damper 1116.The damper 1116 may have a surface 1150 that is funnel shaped and asecond surface 1152 configured to engage the widened portion 1154 of theplunger 1114. It should be understood that the shape of the surface 1152may be varied to create the desired velocity deceleration profile. As anonlimiting example, the surface 1152 may define an interference fitwith the plunger 1114. In another embodiment, the damper 1116 is made ofan elastomeric material and may function to provide more resistanceagainst motion in one direction than another. This may be due in part tothe elastomeric quality of the material which forms about thepenetrating member during withdrawal from the damper 1116 to hold thepenetrating member in. In some embodiments, the damper 1116 iscylindrical about plunger 1114. In other embodiments, the damper 1116may simply be two opposing surfaces 1152 and 1153, without fullysurround the shaft, that provides frictional resistance to the travel ofthe plunger 1114.

Referring now to FIG. 111, a cross sectional view is shown of aspring-based penetrating member driver according to the presentinvention. In the embodiment of FIG. 111, a gripper block 1160 is usedto engage a penetrating member 1020. The gripper block 1160 is coupledto a shaft 1162 that has an enlarged end portion 1164. A drive spring1166 is provided about the shaft 1162 and compresses between the gripperblock 1160 and the protrusion 1168. In one embodiment, a second spring1170 may also be provided and coupled to the shaft 1162 and theprotrusion 1168. In such an embodiment, the second spring 1170 may beconfigured as a return spring to urge the penetrating member 1020 backinto the cartridge after the member has penetrated tissue. In someembodiments, a soft stop 1172 may also be used to assist the return ofthe penetrating member 1020 into the cartridge 1173. A plunger 1174 maybe pulled back in the direction indicated by arrow 1176 to place thegripper block 1160 and the penetrating member 1020 in a launchconfiguration. Release of trigger 1178 will cause the penetrating member1020 to launch.

Referring now to FIG. 112, it shown that in one embodiment where thegripper block extends into the cartridge 1173, the launcher and thecartridge 1173 maybe vertically separated as indicated by arrow 1180 toallow the cartridge 1173 which may be but is not limited to a discshape, to rotate to position an unused penetrating member into contactwith the gripper block 1160. Vertically separating the parts allows thecartridge 1173 to be rotated without the gripper block 1160 interfering.In other embodiments, the gripper block may be designed so that thepenetrating member has a portion that extend upward to engage thegripper block. In still other embodiments, the separation between thecartridge and the launcher may be such that gripper block remains in thecartridge but travels in a radial groove and is lifted enough to allowan unused lancet to be rotated into position. Vertical separation asshown in FIG. 112 may involve the user physically pulling the parts awayfrom each other or using cam surfaces such as those shown in FIG. 55A.

Referring now to FIG. 113, a still further embodiment is shown where acartridge 1200 is shown in a cylindrical configuration. A penetratingmember driver 1202 will be used to engage the penetrating members in thecartridge 1200. As a nonlimiting example, the driver may be anelectromechanical device, a mechanical, spring-based device, or otheractuator as described herein. Each cartridge 1200 may be rotatedclockwise or counterclockwise to position the penetrating members intoactive alignment with the driver 1202. After each cartridge 1200 isready to be disposed, it may be moved forward as indicated by arrow 1204and ejected from the sampling device. Another cartridge 1206 shown inphantom may be move forward by techniques using, but not limited to, astepper motor, mechanical slider, or gravity to replace the usedcartridge 1200. FIG. 114 shows a still further embodiment wherein thepenetrating member driver 1202 is positioned to be within the centeropening of cartridge 1200 to engage each penetrating member. As anonlimiting example, the cartridge 1200 may be advanced by a steppermotor (not shown) or a mechanical slider mechanism to position an unusedpenetrating member into alignment with the driver 1202.

Referring now to FIG. 115, the number of penetrating members remainingin the cartridge 1210 may be determined using a variety of devices. Thecartridge 1210 may have markings or notches 1212 detectable by device1214 which will keep count of the number of penetrating members used. Inother embodiments, a processor 1216 will track the number of actuationsand use that number to determine the number of penetrating members thatremain unused in the cartridge 1210. In such a configuration, theprocessor 1216 may assume that a new cartridge 1210 will contain Xnumber of penetrating members and each actuation will reduce the numberof unused penetrating members. Each time a new cartridge 1210 is loaded,the processor will assume that there are a full X number penetratingmembers available. The processor 1216 may also be coupled to the device1214 to determine when the cartridge 1210 is rotated. FIG. 115 alsoshows in phantom that a display 1218 may also be included to show thenumber of penetrating members remaining or other applicable variables tospring-based penetrating member driver 1220 as disclosed in commonlyassigned, copending U.S. patent application Ser. No. 10/10/335,215 filedDec. 31, 2002. The device may include a slider for rotating thecartridge 1210 as shown in FIG. 56A and/or buttons to adjust settings onthe display. As seen in FIG. 115, a plunger 1222 (shown in phantom) maybe extended to protrude outward from a rear portion of the housing. Insome embodiment the driver or just the plunger 1222 may extend above atop surface of the housing as seen in FIG. 116.

Referring now to FIGS. 117 and 118, still further combinations ofmechanical and electrical actuators are shown. In one embodiment, FIG.117 shows an electric driver 1230 for advancing a gripper block orcoupler 1232 in the direction indicated by arrow 1234. A spring 1236will be extended when the gripper block 1232 is moved. The spring 1236will provide the retraction force and draw the gripper block 1232 andattached penetrating member back. In this embodiment, the electricdriver 1230 will be relaxed or turned off after actuation, thus allowingthe spring 1236 to draw the gripper block 1232 back.

FIG. 118 shows another embodiment where, in the launch configuration,the spring 1236 is extended and the electric driver 1240 is in a forwardposition. From this forward position, the driver 1240 may advance thepenetrating member 1020 into targeted tissue. After reaching desireddepth, a trigger 1242 will release the driver 1240 and pull the entiredriver 1240 and penetrating member 1020 in the direction indicated byarrow 1244. In some embodiments, this withdrawal motion may occur priorto the electric driver finishing its forward stroke.

Referring now to FIGS. 119 and 120, further embodiments of the presentinvention are shown where the depth of penetration into tissue may beset, in part, using a front end apparatus 1250. The front end apparatus1250 is rotated as indicated by arrow 1252. Rotation in either directionwill adjust the vertical separation 1254. This vertical separation 1254will change how close tissue may be placed against the sampling device.The greater the vertical separation 1254, the less the penetratingmember will protrude outward, and the less the penetration depth. FIG.120 shows an embodiment where the front end apparatus 1250 is recessed.This front end apparatus 1250 may be used with any of the penetratingmember drivers described herein.

Referring now to FIG. 121, a still further aspect of a drive mechanismaccording to the present invention will be described. FIG. 121 shows acam groove 1260 that is followed by penetrating member driver. As anonlimiting example, the driver may be a spring based device. The driverhas a protrusion or follower that will follow the path provided by thecam groove 1260 to provide a desired velocity profile. One known devicewhich also uses a cam groove is disclosed in U.S. Pat. No. 5,318,584,fully incorporated herein by reference. The follower 1262 indicated by acircle will follow the groove downward on the inbound stroke portion1264. After reaching maximum penetration, the follower 1262 will travelalong the return portion 1266. This return portion will provide a slowerreturn velocity as the groove 1260 is configured at a shallow slope thatrequires the follower 1262 to follow a longer path that may bring thefollower around the backside of the cylinder as indicated by arrow 1268.This profile can provide a fast-in, slow-out velocity profile desired bysome embodiments of the present invention. As a nonlimiting example, thereturn velocity may be ½, ¼, or any other fraction, percentage orportion of the inbound velocity.

In yet another aspect of the present invention, the current enginefunctions as a variable reluctance device and may be composed of anelectronic drive unit or solenoid, an optical position sensor and amechanism to couple the whole to the lancet. As a nonlimiting example,the penetrating member actuator may comprise of 2×6800 mF capacitors, aCR 123A 3V lithium primary battery, and a 5-coil solenoid of 30G wire.In this embodiment, there is one circuit board, which contains aprocessor (MPS430) for controlling the user interface, and anotherprocessor (SX 28) controlling the drive coils. The penetrating membermay be driven by a series of solenoid coils (of which currently thereare five in this embodiment), which are enclosed in a coil pack andsurround the coupler shaft proximally to the penetrating member. Amagnetic bead or “slug” may be attached to the coupler shaft and isconfigured to slide within the axial lumen of the driver coils. Thedriver coils are made of windings of copper wire, such as but notlimited to about 32 gauge. The coils or “solenoids” drive thepenetrating member using either magnetic attraction or repulsion of theslug.

Several possibilities exist for modification of the current solenoiddrive. The specific advantages to be achieved are a reduction in size,and increase in efficiency, thus reducing power consumption requirementsduring the lancing process.

In one embodiment of the solenoid according to the present invention, afive-coil configuration was conceived because of a desired strokedistance of 8 mm determined from a displacement range needed to coverthe sum of thick stratum corneum (up to 600 mm), tenting of about 1 mmor more and a maximum penetration of up to about 3.5 mm and accelerationdistance enough to reach about 10 m/s. Stroke may be specified as thetotal displacement from one end of travel to the other end, or as aplus/minus. (±) displacement from mid-stroke reference. Since theseexperiments were carried out it has been determined through patienttesting in the lab that shallow lancing to about 1 mm may be sufficientto obtain the volumes of blood required to fill a sample chamber of 0.5μl or less. Stroke distance, in such an embodiment, can therefore bereduced to (maximum tenting+depth+thickest stratum corneum=1 mm+1 mm+0.6mm) 2.6 mm without consequence. This could reduce the number of coils inthe system, reducing the size of the device and therefore lowering cost.It does require a slightly “fatter” set of coils since more turns may beused to maintain the drive power as well as a change in the slug size(longer) to reach the new spacing distance, but overall size shoulddecrease.

In another embodiment of the solenoid, the flat coil embodiment wasinitially proposed as the first approach for driving the lancetelectronically. In one embodiment, it uses a metal flag be attached tothe penetrating member shaft to drive the lancet rather than a metal“slug”. This is somewhat disadvantageous to using bare penetratingmembers. The motivation for the flat coil configuration wasminiaturization of the driver so as to fit in to a handheld glucosespot-monitoring device. Manufacturing of the coils can be by multi-layerprinted circuit board (PCB) so it is straightforward. Such an embodimentis shown in commonly assigned, copending U.S. patent application Ser.No. 38187-2551.

In yet another embodiment of the solenoid, the multi-coil penetratingmember driver with programmable excitation of the various energizingcoils acting on a movable soft-iron “slug” works by timing theexcitation of the various coils to provide motion in the desireddirection. In some known configurations, there may be a series of stable“dead points” where the slug remains stationary unless the local coil isde-energized and the next coil is energized. This can create aninefficient “bumpy” force profile. The “rail-gun” approach provides acoil configuration for continuous (as opposed to step-wise) accelerationof the magnetic slug. It creates the required inhomogeneous magnet fieldto propel the slug and the attached lancet at a progressively increasingspeed towards the target. At no point does the magnetic field of thecoil oppose the desired motion of the slug. It facilitates the “fastentry—delay—slow retraction” mode of operation for minimum pain andmaximum blood recovery. The coil could be wound with an increasingnumber of turns from the start point to the end point creating therequired non-uniform magnetic field profile. A second coil could bewound in the remaining “free” space with increasing turns from theinsertion point to the fully retracted point to implement retraction ofthe lancet, preferably at slow speed, using a weaker current feed. Thiseconomizes on electric drive power demand and uses the available spaceto the best advantage. Any desired time-dependent-profile could beachieved with spatially uniform winding geometry and a programmabletime-dependent current feed with current increasing with time forinsertion, but decreasing with time for retraction

The excitation coils may also be divided into a set of adjacent smallercoils fed with increasing currents from start point to end point, eitheraccording to position or as an increasing function of time. Continuousacceleration (as opposed to a step-wise drive with separate coils in theprior-art multi-coil device) may favor long slim coil geometry. Onepractical advantage is simplicity: in the basic embodiment no electroniccontrol circuitry is required, just a simple on-off current switchingcontrol. However it allows electronic control to be added to determinepenetration depth, using appropriate depth sensing and feedback. Afail-safe feature would be to feed the retraction coil with a weakcontinuous current to ensure that the lancet is always returned to thestart position (full retraction). The soft-iron slug attached to thepenetrating member may be replaced by a small permanent magnet attachedto the penetrating member. Additional disclosure can be found in U.S.patent application Ser. No. 10/127,395 filed Apr. 19, 2002, incorporatedherein by reference.

In another embodiment, slug shaping is based on the goal of increasingthe force or efficiency of the coils by sculpting or changing theprofile of the slug. The chisel point slug also fits in this category.The net result may be to reduce the size of the coil driver.

In one other embodiment, having two slugs in the field rather than onemight increase the sensitivity to position and would require half of theenergy. In addition large variations in force could be avoided makingthe control system more predictable and stable.

In yet another embodiment using a high voltage drive, this is a sizereduction play by substituting the two-capacitor drive with a singlesmaller capacitor. The rationale for the dual capacitor drive is thatthe resistance drops for the two capacitors in parallel and thecirculating currents in the coils should be reduced. Substitution of asingle capacitor will result in an increase in resistance and hence thecurrent requirement goes up and therefore there is a loss of efficiencyof charge storage because of the increase in the voltage drop.

In a further aspect of the present invention, a mechanicalinbound/electric withdrawal configuration may be used for penetratingmember actuation and withdrawal. FIG. 122 shows such an embodiment.Cheap mechanical actuation such as spring or cam drives 1300 may besupplemented by electronic withdrawal device 1310 for slow outretraction of the penetrating member 1020. All of the embodiments belowcan be hybridized with a mechanical spring or cam driven inboundactuation. The mechanical inbound drives 1300 may be used with a softbraking mechanism such as but not limited to a soft stop 1312 or anyother damping device disclosed herein or known to one of skill in theart. In the embodiment shown in FIG. 122, the withdrawal device 1310 maybe used to move the entire carrier 1314 having the mechanical inbounddrive 1300. The use of electric withdrawal of a penetrating member 1020from the anatomical feature at velocity less than that on the inboundmay be used to increase the likelihood spontaneous fluid generation froma wound created in the feature. These components may all be contained ina housing 1320 (shown in phantom) that may optionally include anadjustable front end 1322 for adjusting depth of penetrating memberpenetration.

Referring now to FIG. 123, the device 1310 is not coupled to the carrier1314. It maybe used to withdraw the spring launched penetrating member1020 as indicated by arrow 1324. This allows the spring device to bepulled back and in some embodiments, reset for the next lancing event.It should be understood that the soft stop 1312 may also be configuredto be on both sides of the penetrating member as shown in FIG. 122.

In one embodiment of the present invention, a DC Gear motor may be usedas the device 1310. In an embodiment similar that shown in FIG. 102,spring actuation or dashpot can be used for the inbound and the springstays compressed against the dashpot. The motor 1042 drags the dashpotback and compresses the spring on its way. It can even re-cock thespring. This is a small DC motor with a speed reducing gear head. The DCmotor can drive a jackscrew such that the withdrawal can be achieved insmall steps as required by switching the motor on and off (see 1042).Position feedback may be used for better control. These motors are cheapand mass manufactured for cameras, toys and therefore this would be acost reduction play.

In yet another embodiment of the present invention, a stepper motor mayalso be used as the device 1310. The stepper motor can replace the gearmotor and tend to run at a lower speed. It can run open loop so thatposition feedback would not be required. These motors are precise andwould give amore compact package and better control method. In yetanother embodiment of the present invention, a inductive motor may beused. This was the very first concept investigated for driving thelancet due to its ability to move penetrating members at high speeds andlarge throw. Unfortunately it is not very efficient due hystereticlosses, and the control problem is complicated.

In yet another embodiment of the present invention, a nanomuscle may beused as device 1310. Nanomuscle actuators are based on shape memoryalloys, that, when heated, their crystalline structures change and thisresult in mechanical contraction. Current is passed through the alloysto heat them. They claim to be over five times more efficient than a DCmicro actuator of the equivalent size, faster and lighter. In oneembodiment, they are about the size of a paperclip and are capable of1,000,000 actuations. There are also supposed to produce rated forceover their entire trajectory and allow position, speed and force to becontrolled. In one embodiment, the extent of the nanomuscle stroke isabout 4.0 mm, which should be enough to cover shallow lancing depth fora range of skin types. For a higher displacement or throw, severalnano-muscles could be placed in series, thus raising the cost. Powerconsumption in the nanomuscle actuator is much less on the retractionphase than the actuation phase, which is why these devices weresuggested for lancet withdrawal.

In yet another embodiment of the present invention, a liquid magneticcoil may be used as device 1310. Energy stored in a compressed spring,gas, or other means is released to actuate a penetrating member towardsthe skin or an anatomical feature. In one nonlimiting example, thevelocity trajectory of the penetrating member is controlled by aniron-loaded fluid that changes viscosity in response to an imposedmagnetic field. The current can be switched on when a desired slowing inthe spring withdrawal (or inbound trajectory—see below for details anddrawing) to produce a controlled withdrawal profile. The withdrawalprofile could be computer controlled so that switching on the fieldoccurs in a specified pattern to simulate the best profile.

In yet another embodiment of the present invention, a electromechanicalhybrid may be used. As a nonlimiting example, cheap electronic drive forinbound (hybrid spring and magnetic fluid), combined with cheapelectronic for withdrawal using the same hybrid design may be a way todesign a cost effective device with performance requirements to achievelow pain and spontaneity. Alternatively a motor can be used to controlthe retraction rate of the lancet from the skin if it is more costeffective or performs better on the withdrawal phase. Many miniaturizedmotors tested have been deficient in either the inbound speed or thethrow, so it may be that two different engine types will have to becontemplated to achieve the speed and throw of the current design.

In yet another embodiment of the present invention, a hybrid liquidmagnetic coil may be used. A version of the hybrid electromechancialdevice for both actuation and retraction is shown below. Theelectromagnetic field generator 1052 is coupled to a power source 1054controlled by a processor 1012.

Some embodiments of the present invention may also be configured to usea mechanical inbound with slow mechanical withdrawal or outbound device.As a nonlimiting example similar to that used with a cassette playerlid, a dashpot device and would be coupled with a spring. This is aWYSIWYG system, so withdrawal will be at a (uncontrolled) uniform rate.No user definable withdrawal profile is the disadvantage of this set up.

In another nonlimiting example, a wax or other material with highthermal coefficient of expansion could be heated. As it expands anddisplaces a piston, it is coupled to a mechanism to withdraw the lancet.Similar to nanomuscle in actuation by heating.

In a still further nonlimiting example, a piezo electric bendingmechanism may be used. There are electromechanical transducers thatpossess high motion and voltage sensitivity. Generally in motorapplications two piezoelectric sheets are bonded together, one layerexpands laterally and the other layer contracts when an electric fieldis applied. The opposing strains result in a deflection, which isproportional to the applied voltage, generating a displacement at lowlevels of electrical drive.

In a still further nonlimiting example, a traction drive may be used. Aspinning rubber tire running at constant speed driven by DC motor drivesa flat plate in contact with its outer circumference to withdraw thelancet and compressing the actuation spring This can be used in the samemanner to actuate as well as withdraw the device.

FIG. 124 shows a schematic view of a penetrating member driver 1350where the drive may be, but is not limited to, a nanomuscle, a liquidmagnetic coil actuation, a stepper motor, a micro-clutch device, and aninductive motor. The driver 1350 may be used to provide both inbound andoutbound motion for the penetrating member 1020 attached to a coupler1034.

Referring now to FIGS. 125 and 126, embodiments of the present inventionmay comprise kits containing any of the penetrating member actuators1430 disclosed herein. The kit may further include instructions for useIFU setting forth any of the methods described above. Optionally, thekit may further comprise a cartridge containing a plurality ofpenetrating members. The cartridge 1432 may be of any of the embodimentsdisclosed herein. Usually, the kit components will be packaged togetherin a pouch P or other conventional medical device packaging, such as abox, tray, tube, or the like. In many embodiments, the cartridge will bedisposable. The cartridge 1432 may itself be contained in a separatepouch or container and then inserted into the container P. In someembodiments, the IFU may be printed on the container P. In a nonlimitingexample, the container P may only contain an actuator 1430, without thecartridge 1432.

Referring now to FIG. 125, embodiments of the present invention mayinclude kits that only include a cartridge 1432. IFU may also beincluded. In some embodiments, a plurality of cartridges 1432 (shown inphantom) may be included. Any of the elements in these figures or otherelements described in this application may be placed in the container P,singly or in any combination. It should also be understood that thecartridges maybe of any shape as disclosed herein and are not limited todisc shaped embodiments.

Referring now to FIG. 126, a still further embodiment according to thepresent invention will now be described. FIG. 126 shows an embodiment ofa sampling device 1448 having a plurality of penetrating members 1450housing in a cartridge (not shown) in the housing 1452. The penetratingmembers 1450 may be operatively coupled to a penetrating member driver1454 to extend the penetrating member 1450 from a penetrating memberexit 1456. In this embodiment, a test strip 1460 may be extended outwardfrom a opening 1462 in a housing 1464. It should be understood that insome embodiments, the housing 1452 and housing 1464 may be integratedtogether into a single housing. In other embodiments, the housings 1452and 1464 may be separate devices that are coupled together. They mayrotate in the same direction or in some embodiments may rotate inopposite directions. The housing 1464 may have its own slider oractuator for extending the test strip 1460 out from the housing 1464.The test strip may be of a type known to those of skill in the art formeasuring analytes in a body fluid. One suitable device suitable for ahousing 1464 is described in U.S. Pat. No. 5,854,074 to Charlton et al.,fully incorporated herein by references for all purposes. Although notlimited to the following, the penetrating member driver 1454 may be aspring based launcher or any of the driver or combination of driversdisclosed herein.

FIG. 127 shows that the device of FIG. 126 may also be configured sothat penetrating member 1450 is on top while the test strip 1460 is onthe bottom (when held horizontally). FIG. 128 shows that the device 1448may be used in a vertical orientation. FIG. 129 shows that the device1448 may also be used in a horizontal orientation. As seen in FIG. 129,the test strip 1460 may be made of flexible material such as a polymeror other material as known to those of skill in the art. This may allowgravity to bend the strip 1460 as shown in FIG. 129 to bring the stripcloser to the wound W on the tissue. Although not limited to thefollowing, some embodiments of the test strip 1460 may have a capillarychannels, tubes or members to draw fluid into the test strip 1460.Wicking members, wicking materials, or absorbent materials may also beused in other embodiments of the test strip or any of the above may becombined in any order on a test strip. In some embodiments, the teststrip 1460 may be oriented to extend outward at a diagonal, relative tothe penetrating member, so that the distal end of the strip 1460 will bebrought closer to the wound created by the penetrating member.

Referring now to FIG. 130, one embodiment of a cartridge 1470 accordingto the present invention and suitable for use with device 1448. Thecartridge 1470 may be rotated as indicated by arrow 1472. One suitabledevice suitable for cartridge 1470 is described in U.S. Pat. No.5,854,074 to Charlton et al., fully incorporated herein by referencesfor all purposes. In one embodiment, the test strip 1460 may be ejectedfrom the sealed container area 1474 to engage fluid from the wound.After use, the test strip 1460 may be removed from the cartridge or itmay be reinserted into the cartridge. In some embodiments, the teststrip 1460 may be coupled to electrode leads 1476 which extend back tocontact pads 1478 that allow an analysis device to receive signal from atest strip. In one embodiment, a penetrating member 1450 (shown inphantom in FIG. 130) may be associated with each test strip 1460. Insome embodiments, the penetrating member 1450 may be in the samecartridge 1470 or in a separate cartridge in other embodiments. Itshould be understood that the cartridge 1470 may be modified to includethe features of the device disclosed in U.S. Pat. No. 5,854,074 toCharlton et al. In other embodiments, the penetrating member 1451 may bealigned to one side or the other of container 1474.

Referring now to FIG. 131, a still further embodiment of the presentinvention will now be described. A penetrating member 1480 is housed ina cavity 1482. A sterility barrier 1484 is used to maintain thepenetrating member 1480 and analyte detecting members 1486 in a sterileenvironment. In some embodiments, these analyte detecting members 1486may be coupled to electrode leads to bring signals to an analytemeasurement device. In still further embodiments, one or morefracturable seals 1487 (shown in phantom) may be included with thedevice.

FIG. 132 shows the cartridge 1478 with the sterility barrier pealed backrevealing the analyte detecting members 1486 and the penetrating member1480. It should be understood that some embodiment may use only a singleanalyte detecting member 1486. Others may use analyte detecting members1486 that operate in the optical domain. The analyte detecting members1486 may be individual elements as seen in FIG. 132. In otherembodiments, analyte detecting members 1486 maybe circular in shape orother shape to take up the entire area 1488, substantially encirclingthe penetrating member exit.

Referring now to FIG. 133, a still further embodiment of the presentinvention is shown. The cartridge 1500 includes a plurality of teststrips 1502. The test strips 1502 may be oriented as shown or may beconfigured as indicated by the test strip 1504 (shown in phantom). Asecond cartridge 1506 containing a plurality of penetrating members maybe placed or lowered about the cartridge 1500. In some embodiments, thecartridges 1500 and 1506 may be integrated together. The penetratingmembers in the cartridge 1506 may extend outward as indicated by arrows1508. In one embodiment, the penetrating members extend outward whenthey are in the active position and are operatively coupled to thepenetrating member driver. The test strips may extend outward insubstantially the same direction as the arrows 1508. A suitable devicefor cartridge 1500 is shown in U.S. Pat. No. 5,510,266 to Bonner, fullyincorporated herein by reference for all purposes.

Referring now to FIG. 134, yet another embodiment of the presentinvention is shown. A cartridge 1500 is shown having a plurality of teststrips 1502. In some embodiments, the test strip 1502 is raised so thatthe strip is brought near but is not pierced by the penetrating member.In other embodiments, the penetrating member 1450 may pierce the teststrip 1502. A housing (not shown) may be implemented hold these devicesin the orientations shown.

Referring now to FIG. 135, a still further embodiment of a cartridge1520 according to the present invention is shown. There are portions1522 where a plurality of penetrating members 1524 are housed. Apenetrating member coupler (not shown) may be moved as indicated byarrows 1526. In another embodiment, the entire cartridge is rotated asindicated by arrow 1528. After the cartridge 1520 has made one completerevolution, the penetrating member holder may be moved over one positionas indicated by arrow 1526. The entire cartridge 1520 is then rotatedagain through one revolution, before the penetrating member coupler isshifted one more position as indicated by arrow 1528.

Referring now to FIG. 136, a still further embodiment is shown where aplurality of analyte detecting members 1502 are shown in a stackconfiguration. After each detecting member 1502 is used, it may beremoved and a new one will be revealed. It may also be pushed up by abiasing member (not shown). The cartridge 1540 may be integrated withthe cartridge 1452. It may also be shaped to be similar to the shape ofcartridge 1452. Still further, a housing may be used to hold a cartridge1540 in relation to the cartridge 1452. A user interface 1542 may becoupled to the device. A processor 1544 may be coupled to the device. Aposition sensor 1546 may be incorporated with the device so that lancingperformance and/or tracking of position of the driver (and thus thepenetrating member) may be monitored. Any of the embodiments of thepresent invention may be modified to include these elements.

While the invention has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, with any of the above embodiments, the location of thepenetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). With any of the above embodiments, thepenetrating members may be a bare penetrating member during launch. Withany of the above embodiments, the penetrating members may be barepenetrating members prior to launch as this may allow for significantlytighter densities of penetrating members. In some embodiments, thepenetrating members may be bent, curved, textured, shaped, or otherwisetreated at a proximal end or area to facilitate handling by an actuator.The penetrating member may be configured to have a notch or groove tofacilitate coupling to a gripper. The notch or groove may be formedalong an elongate portion of the penetrating member. With any of theabove embodiments, the cavity may be on the bottom or the top of thecartridge, with the gripper on the other side. In some embodiments,analyte detecting members may be printed on the top, bottom, or side ofthe cavities. The front end of the cartridge maybe in contact with auser during lancing. The same driver may be used for advancing andretraction of the penetrating member. The penetrating member may have adiameters and length suitable for obtaining the blood volumes describedherein. The penetrating member driver may also be in substantially thesame plane as the cartridge. The driver may use a through hole or otheropening to engage a proximal end of a penetrating member to actuate thepenetrating member along a path into and out of the tissue.

Any of the features described in this application or any referencedisclosed herein may be adapted for use with any embodiment of thepresent invention. For example, the devices of the present invention mayalso be combined for use with injection penetrating members or needlesas described in U.S. patent application Ser. No. 10/127,395 filed Apr.19, 2002. An analyte detecting member to detect the presence of foil mayalso be included in the lancing apparatus. For example, if a cavity hasbeen used before, the foil or sterility barrier will be punched. Theanalyte detecting member can detect if the cavity is fresh or not basedon the status of the barrier. It should be understood that in optionalembodiments, the sterility barrier may be designed to pierce a sterilitybarrier of thickness that does not dull a tip of the penetrating member.The lancing apparatus may also use improved drive mechanisms. Forexample, a solenoid force generator may be improved to try to increasethe amount of force the solenoid can generate for a given current. Asolenoid for use with the present invention may have five coils and inthe present embodiment the slug is roughly the size of two coils. Onechange is to increase the thickness of the outer metal shell or windingssurround the coils. By increasing the thickness, the flux will also beincreased. The slug may be split; two smaller slugs may also be used andoffset by ½ of a coil pitch. This allows more slugs to be approaching acoil where it could be accelerated. This creates more events where aslug is approaching a coil, creating a more efficient system.

In another optional alternative embodiment, a gripper in the inner endof the protective cavity may hold the penetrating member during shipmentand after use, eliminating the feature of using the foil, protectiveend, or other part to retain the used penetrating member. Some otheradvantages of the disclosed embodiments and features of additionalembodiments include: same mechanism for transferring the usedpenetrating members to a storage area; a high number of penetratingmembers such as 25, 50, 75, 100, 500, or more penetrating members may beput on a disk or cartridge; molded body about a lancet becomesunnecessary; manufacturing of multiple penetrating member devices issimplified through the use of cartridges; handling is possible of barerods metal wires, without any additional structural features, to actuatethem into tissue; maintaining extreme (better than 50 micron—lateral—andbetter than 20 micron vertical) precision in guiding; and storage systemfor new and used penetrating members, with individual cavities/slots isprovided. The housing of the lancing device may also be sized to beergonomically pleasing. In one embodiment, the device has a width ofabout 56 mm, a length of about 105 mm and a thickness of about 15 mm.Additionally, some embodiments of the present invention may be used withnon-electrical force generators or drive mechanism. For example, thepunch device and methods for releasing the penetrating members fromsterile enclosures could be adapted for use with spring based launchers.The gripper using a frictional coupling may also be adapted for use withother drive technologies.

Still further optional features may be included with the presentinvention. For example, with any of the above embodiments, the locationof the penetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). The penetrating members may be a barepenetrating member during launch. In some embodiments, the penetratingmember may be a patent needle. The same driver may be used for advancingand retraction of the penetrating member. Different analyte detectingmembers detecting different ranges of glucose concentration, differentanalytes, or the like may be combined for use with each penetratingmember. Non-potentiometric measurement techniques may also be used foranalyte detection. For example, direct electron transfer of glucoseoxidase molecules adsorbed onto carbon nanotube powder microelectrodemay be used to measure glucose levels. In some embodiments, the analytedetecting members may formed to flush with the cartridge so that a“well” is not formed. In some other embodiments, the analyte detectingmembers may formed to be substantially flush (within 200 microns or 100microns) with the cartridge surfaces. In all methods, nanoscopic wiregrowth can be carried out via chemical vapor deposition (CVD). In all ofthe embodiments of the invention, preferred nanoscopic wires may benanotubes. Any method useful for depositing a glucose oxidase or otheranalyte detection material on a nanowire or nanotube may be used withthe present invention. Additionally, for some embodiments, any of thecartridge shown above may be configured without any of the penetratingmembers, so that the cartridge is simply an analyte detecting device.Still further, the indexing of the cartridge may be such that adjacentcavities may not necessarily be used serially or sequentially. As anonlimiting example, every second cavity may be used sequentially, whichmeans that the cartridge will go through two rotations before every orsubstantially all of the cavities are used. As another nonlimitingexample, a cavity that is 3 cavities away, 4 cavities away, or Ncavities away may be the next one used. This may allow for greaterseparation between cavities containing penetrating members that werejust used and a fresh penetrating member to be used next. It should beunderstood that the spring-based drivers shown in the present invention(FIGS. 98-112) may be adapted for use with any of the cartridges shownherein such as, but not limited to, those shown in FIGS. 61 and 62.These spring-based drivers may also be paired with gripper blocks thatare configured to penetrate into cartridges that fully seal penetratingmember therein, in order engage those penetrating members. The start andend positions of the penetrating members may also be the same. Thepenetrating members may be parked in a holder before actuation, and insome embodiments, into a holder after actuation (as seen in cartridge500 or any other cartridge herein). Embodiments of the present inventionmay also include guides which provide lateral constraints and/orvertical constraints about penetrating member. These constraints may bepositioned about the shaft portions of the penetrating member.

This application cross-references commonly assigned copending U.S.patent application Ser. No. 10/323,622 filed Dec. 18, 2002; commonlyassigned copending U.S. patent application Ser. No. 10/323,623 filedDec. 18, 2002; and commonly assigned copending U.S. patent applicationSer. No. 10/323,624 filed Dec. 18, 2002. This application is alsorelated to commonly assigned copending U.S. patent application Ser. Nos.10/335,142, 10/335,215, 10/335,258, 10/335,099, 10/335,219, 10/335,052,10/335,073, 10/335,220, 10/335,252, 10/335,218, 10/335,211, 10/335,257,10/335,217, 10/335,212, and 10/335,241, 10/335,183, filed Dec. 31, 2002.All applications listed above are fully incorporated herein by referencefor all purposes. Expected variations or differences in the results arecontemplated in accordance with the objects and practices of the presentinvention. It is intended, therefore, that the invention be defined bythe scope of the claims which follow and that such claims be interpretedas broadly as is reasonable.

1. A body fluid sampling system for use on a tissue site, the systemcomprising: a cartridge; a penetrating member driver; a plurality ofpenetrating members arranged in a radial configuration on the cartridgewherein sharpened distal tips of the penetrating members point radiallyoutward; wherein an active one of said penetrating members may beoperatively coupled to said penetrating member driver, said penetratingmember driver moving said active one along a path out of a housinghaving a penetrating member exit, into said tissue site, stopping insaid tissue site, and withdrawing out of said tissue site; and aplurality of analyte detecting members, wherein at least one of saidanalyte detecting members is positioned to receive fluid from a woundcreated by said active one of said penetrating members, wherein saiddetecting members are not pierced by the active one of the penetratingmembers; a position sensor positioned to provide an indication of aposition of the penetrating member during actuation.